Nicolet Biomedical Instruments
Mchenry, IL, US
Nicolet Biomedical Instruments appears in FDA device records in Mchenry, IL. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Nicolet Biomedical Instruments between 1977 and 1988. The busiest year on record is 1985, with 5. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 1 |
| 1987 | 4 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K880573 | MODIFIED NICOLET VIKING SYSTEM | IKN | Substantially Equivalent | |
| K873736 | NICOLET DIGITAL TWO PIECE HEARING AID | ESD | Substantially Equivalent | |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | ETN | Substantially Equivalent | |
| K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM | GWQ | Substantially Equivalent | |
| K871678 | NICOLET AMP 6R11 SYSTEM | GWL | Substantially Equivalent | |
| K862592 | PHOENIX SYSTEM SEVEN. | EWO | Substantially Equivalent | |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | GWN | Substantially Equivalent | |
| K850259 | ELECTROENCEPHALOGRAPH EEG | GWQ | Substantially Equivalent | |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | GXY | Substantially Equivalent | |
| K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | GXZ | Substantially Equivalent | |
| K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF | GWK | Substantially Equivalent | |
| K842956 | NICOLET VIKING | IKN | Substantially Equivalent | |
| K842613 | COMPACT VISUAL | IKN | Substantially Equivalent | |
| K842612 | COMPACT AUDITORY | IKN | Substantially Equivalent | |
| K842611 | CA2000 | IKN | Substantially Equivalent | |
| K831896 | COMPACT FOUR | GWF | Substantially Equivalent | |
| K830702 | NICOLET EMG SATELLITE | IKN | Substantially Equivalent | |
| K830579 | MULTI-SIGNAL AUDITORY STIMULATOR SM700 | GWJ | Substantially Equivalent | |
| K822215 | NIC OPTRONICS CS-2000 | HOX | Substantially Equivalent | |
| K813399 | ERG-JET ELECTRODE | HLZ | Substantially Equivalent | |
| K812331 | VTS-1000 VISUAL TESTING SYSTEM | HLX | Substantially Equivalent | |
| K802149 | TM-5 INTRACRANIAL PRESSURE MONITOR | GWM | Substantially Equivalent | |
| K801604 | PATHFINDER ELECTRODIAGNOSTIC SYSTEM | GWK | Substantially Equivalent | |
| K792466 | NIC-200 VENTRICULAR FUNCTION ANALYZER | DQC | Substantially Equivalent | |
| K790570 | STIMULATOR, NIC-106 VISUAL | GWE | Substantially Equivalent | |
| K771449 | ARTEOIAL TONOMETER ML-105 | DXN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GWLAmplifier, Physiological Signal
- EWOAudiometer
- HOXChart, Visual Acuity
- GWKConditioner, Signal, Physiological
- GWMDevice, Monitoring, Intracranial Pressure
- HLZElectrode, Corneal
- GXYElectrode, Cutaneous
- GXZElectrode, Needle
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- ESDHearing Aid, Air-Conduction, Prescription
- GWNNystagmograph
- DQCPhonocardiograph
- HLXPhotostimulator, Ac-Powered
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- GWEStimulator, Photic, Evoked Response
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain