Medical Device Manufacturer · US , Clarence , NY

Mennen Medical, Inc.

34 submissions · 34 cleared · Since 1985
34
Total
34
Cleared
0
Denied

Mennen Medical, Inc. — FDA 510(k) Submissions

Mennen Medical, Inc. has submitted 34 FDA 510(k) premarket notifications since 1985, of which 34 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Detector And Alarm, Arrhythmia, Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm), Electrocardiograph, Computer, Diagnostic, Pre-programmed, Single-function, Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia . Use the specialty filter in the sidebar to narrow results.

34 devices
1–12 of 34
ENVOY PATIENT MONITOR
K030722 · MHX Monitor, Physiological,... · Cardiovascular
Feb 2004 356d
ETCO2 VITAL SIGNS MODULE
K983864 · CCK Analyzer, Gas,... · Anesthesiology
Oct 1999 340d
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K991775 · DXG Computer, Diagnostic,... · Cardiovascular
Jun 1999 30d
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K982697 · DSI Detector And Alarm,... · Cardiovascular
Aug 1998 9d
ENVOY PATIENT MONITOR
K974510 · DSI Detector And Alarm,... · Cardiovascular
Apr 1998 134d
ENSEMBLE CENTRAL STATION MONITOR
K970358 · DSI Detector And Alarm,... · Cardiovascular
Feb 1998 377d
MERCURY
K940081 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Apr 1995 460d
HORIZON 9000 WS
K940415 · DXG Computer, Diagnostic,... · Cardiovascular
Jan 1995 343d
CAPNOMED 100 STAND-ALONE ETCO2 MODULE
K920915 · CCK Analyzer, Gas,... · Anesthesiology
Mar 1993 390d
HORIZON 9000/HIS OPTION AMPLIFIER
K914381 · DRR Amplifier And Signal... · Cardiovascular
Jan 1992 117d
HORIZON PACEMAKER DETECTION SOFTWARE
K913339 · DSI Detector And Alarm,... · Cardiovascular
Jan 1992 166d
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Aug 1991 151d
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