Mennen Medical, Inc.
Rehovot, IL
Mennen Medical, Inc. appears in FDA device records in Rehovot, IL. FDA records list 55 510(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
- 55
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Mennen Medical, Inc. between 1985 and 2015. The busiest year on record is 1989, with 8. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 8 |
| 1990 | 2 |
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 2 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| 2007 | 4 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 2 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141441 | MENNTOR X7 | DSI | Substantially Equivalent | |
| K131789 | CEREBRALOGIK- AEEG | OMA | Substantially Equivalent | |
| K123792 | HORIZON XVU (FFR) | DQX | Substantially Equivalent | |
| K093766 | VITALOGIK 6000/6500 | DSI | Substantially Equivalent | |
| K091165 | HORIZON XVU | DQK | Substantially Equivalent | |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | OLW | Substantially Equivalent | |
| K081484 | HORIZON XVU | DQK | Substantially Equivalent | |
| K073140 | VITALOGIK MODEL 4000/4500 | DSI | Substantially Equivalent | |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | OLW | Substantially Equivalent | |
| K071348 | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM | DQK | Substantially Equivalent | |
| K070254 | HORIZON SE | DQK | Substantially Equivalent | |
| K052288 | VITALOGIK | DSI | Substantially Equivalent | |
| K043564 | HORIZON ANGIO CATHLAB | DQK | Substantially Equivalent | |
| K024245 | ENVOY PATIENT MONITOR | OMC | Substantially Equivalent | |
| K030722 | ENVOY PATIENT MONITOR | MHX | Substantially Equivalent | |
| K032997 | MODIFICATION TO: HORIZON 9000WS | DXG | Substantially Equivalent | |
| K023798 | MODIFICATION TO ENVOY PATIENT MONITOR | DSI | Substantially Equivalent | |
| K022168 | ENVOY | DQA | Substantially Equivalent | |
| K020632 | ENGUARD REMOTE PATIENT MONITOR | QYX | Substantially Equivalent | |
| K011784 | MODIFICATION TO ENVOY PATIENT MONITOR | DSI | Substantially Equivalent | |
| K001120 | ENVOY PATIENT MONITOR | DSI | Substantially Equivalent | |
| K000563 | MODIFICATION TO ENVOY PATIENT MONITOR | MHX | Substantially Equivalent | |
| K983864 | ETCO2 VITAL SIGNS MODULE | CCK | Substantially Equivalent | |
| K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS | DXG | Substantially Equivalent | |
| K982697 | MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR | DSI | Substantially Equivalent | |
| K974510 | ENVOY PATIENT MONITOR | DSI | Substantially Equivalent | |
| K970358 | ENSEMBLE CENTRAL STATION MONITOR | DSI | Substantially Equivalent | |
| K940081 | MERCURY | DRT | Substantially Equivalent | |
| K940415 | HORIZON 9000 WS | DXG | Substantially Equivalent | |
| K920915 | CAPNOMED 100 STAND-ALONE ETCO2 MODULE | CCK | Substantially Equivalent | |
| K914381 | HORIZON 9000/HIS OPTION AMPLIFIER | DRR | Substantially Equivalent | |
| K913339 | HORIZON PACEMAKER DETECTION SOFTWARE | DSI | Substantially Equivalent | |
| K911257 | MR-5200 FULL DISCLOSURE SYSTEM | DSH | Substantially Equivalent | |
| K910945 | HORIZON 2000 EEG MONITORING OPTION | GWQ | Substantially Equivalent | |
| K911616 | HORIZON XL | DRT | Substantially Equivalent | |
| K903524 | HORIZON 2000 ST ANALYSIS OPTION | DPS | Substantially Equivalent | |
| K901774 | HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL | DQA | Substantially Equivalent | |
| K895895 | MODEL 219 TELEMETRY SYSTEM | GYE | Substantially Equivalent | |
| K894918 | HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. | CCL | Substantially Equivalent | |
| K893585 | 14 COLOR VIDEO DISPLAY 211-260-010 | LLZ | Substantially Equivalent | |
| K893133 | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX | KLK | Substantially Equivalent | |
| K892066 | HORIZON CENTRAL STATION | DRT | Substantially Equivalent | |
| K884423 | HORIZON DISPLAY CONTROLLER PART # 266-200-010 | DXJ | Substantially Equivalent | |
| K885204 | HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) | DSI | Substantially Equivalent | |
| K884897 | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER | DSF | Substantially Equivalent | |
| K885079 | HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 | LPP | Substantially Equivalent | |
| K882273 | HORIZON 2000 PULSE OXIMETRY AND MODULE | DQA | Substantially Equivalent | |
| K881273 | HORIZON 2000 ARRHYTHMIA MONITORING OPTION | DSI | Substantially Equivalent | |
| K875167 | HORIZON 9000 | DXG | Substantially Equivalent | |
| K880595 | HORIZON 2000/S 266-XXX-XXX | DPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DRRAmplifier And Signal Conditioner, Biopotential
- OMAAmplitude-Integrated Electroencephalograph
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- GYEEncephalogram Telemetry System
- GWQFull-Montage Standard Electroencephalograph
- OLWIndex-Generating Electroencephalograph Software
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- QYXOutpatient Cardiac Telemetry
- DQAOximeter
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- OMCReduced- Montage Standard Electroencephalograph
- LLZSystem, Image Processing, Radiological
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain