Bio-Logic Systems Corp.
Mudelein, IL, US
Bio-Logic Systems Corp. appears in FDA device records in Mudelein, IL. FDA records list 57 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Bio-Logic Systems Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Natus Medical, Inc.510(k), recall
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Bio-Logic Systems Corp. between 1981 and 2012. The busiest year on record is 1995, with 5. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 4 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 3 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | EWO | Substantially Equivalent | |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | EWO | Substantially Equivalent | |
| K093304 | PROTEKTOR 32 | GWF | Substantially Equivalent | |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | OMA | Substantially Equivalent | |
| K090019 | NATUS NEUROWORKS, MODEL 104196 | OMB | Substantially Equivalent | |
| K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | GWF | Substantially Equivalent | |
| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | GWJ | Substantially Equivalent | |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | GWJ | Substantially Equivalent | |
| K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS | EWO | Substantially Equivalent | |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | LBI | Substantially Equivalent | |
| K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER | OLV | Substantially Equivalent | |
| K031352 | BIO-LOGIC INSERT EARPHONES | EWO | Substantially Equivalent | |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | GWJ | Substantially Equivalent | |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | GWJ | Substantially Equivalent | |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | GWJ | Substantially Equivalent | |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | LBI | Substantially Equivalent | |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | GWJ | Substantially Equivalent | |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | EWO | Substantially Equivalent | |
| K021215 | BIO-LOGIC ABAER CUB | GWJ | Substantially Equivalent | |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | GWJ | Substantially Equivalent | |
| K012384 | EAR MUFFINS | HCC | Substantially Equivalent | |
| K003681 | BIO-LOGIC SLEEPSCAN NETLINK | OLV | Substantially Equivalent | |
| K002570 | BIO-LOGIC CEEGRAPH NETLINK | GWQ | Substantially Equivalent | |
| K994149 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. | GWJ | Substantially Equivalent | |
| K992807 | BIO-LOGIC EVOKED POTENTIAL FOR ABAER I | GWJ | Substantially Equivalent | |
| K983913 | MODIFICATION TO BIO-LOGIC SLEEPSCAN | OLV | Substantially Equivalent | |
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | GHS | Substantially Equivalent | |
| K973883 | BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM | GWQ | Substantially Equivalent | |
| K974076 | SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE | EWO | Substantially Equivalent | |
| K971501 | SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER | MNR | Substantially Equivalent | |
| K964132 | MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT | EWO | Substantially Equivalent | |
| K962103 | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER | MNR | Substantially Equivalent | |
| K961447 | SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT | EWO | Substantially Equivalent | |
| K954954 | CEEGRAPH TRAVELER AMBULATORY EEG RECORDER | GWQ | Substantially Equivalent | |
| K944314 | DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123 | GXY | Substantially Equivalent | |
| K951594 | BIO-LOGIC AUTOMATIC EVENT ANALYSIS | OMB | Substantially Equivalent | |
| K935160 | MINIMUFFS | EWE | Substantially Equivalent | |
| K941928 | VARIOUS ELECTRODES | GWN | Substantially Equivalent | |
| K941799 | DISPOSABLE CUTANEOUS ELECTRODES | GXY | Substantially Equivalent | |
| K936039 | ALGO-2 NEWBORN HEARING SCREENER | GWJ | Substantially Equivalent | |
| K944735 | BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST | EWO | Substantially Equivalent | |
| K933233 | CEEGRAPH, MODIFICATION | GWQ | Substantially Equivalent | |
| K930790 | ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. | BZQ | Substantially Equivalent | |
| K930328 | NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT | IKN | Substantially Equivalent | |
| K893130 | EMG NAVIGATOR & EMG TRAVELER | IKN | Substantially Equivalent | |
| K895125 | CEEGRAPH | GWQ | Substantially Equivalent | |
| K874136 | PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL | GWE | Substantially Equivalent | |
| K872290 | BIO-LOGIC BANKER | GWK | Substantially Equivalent | |
| K870337 | AUDIOMETER | ETW | Substantially Equivalent | |
| K862690 | TRAVELER LT | GWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OMAAmplitude-Integrated Electroencephalograph
- GHSAssay, Carboxyhemoglobin
- EWOAudiometer
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems
- GWKConditioner, Signal, Physiological
- HCCDevice, Biofeedback
- GXYElectrode, Cutaneous
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- BZQMonitor, Breathing Frequency
- GWNNystagmograph
- EWEProtector, Hearing (Circumaural)
- OLVStandard Polysomnograph With Electroencephalograph
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GWEStimulator, Photic, Evoked Response
- LBIUnit, Neonatal Phototherapy
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2165-2010 | SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154 | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. | Terminated | ||
| Z-0001-2008 | Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video. | Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall. | Terminated | ||
| Z-0761-2007 | Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG) | Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating. | Terminated | ||
| Z-0985-05 | Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.) | Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain