Medical Device Manufacturer · US , Clarence , NY

Mennen Medical, Inc. - FDA 510(k) Cleared Devices

34 submissions · 34 cleared · Since 1985
34
Total
34
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mennen Medical, Inc. Cardiovascular
23 devices
1-23 of 23
Cleared Feb 26, 2004
ENVOY PATIENT MONITOR
K030722 · MHX
Cardiovascular · 356d
Cleared Jun 24, 1999
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K991775 · DXG
Cardiovascular · 30d
Cleared Aug 12, 1998
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K982697 · DSI
Cardiovascular · 9d
Cleared Apr 14, 1998
ENVOY PATIENT MONITOR
K974510 · DSI
Cardiovascular · 134d
Cleared Feb 11, 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358 · DSI
Cardiovascular · 377d
Cleared Apr 12, 1995
MERCURY
K940081 · DRT
Cardiovascular · 460d
Cleared Jan 06, 1995
HORIZON 9000 WS
K940415 · DXG
Cardiovascular · 343d
Cleared Jan 28, 1992
HORIZON 9000/HIS OPTION AMPLIFIER
K914381 · DRR
Cardiovascular · 117d
Cleared Jan 08, 1992
HORIZON PACEMAKER DETECTION SOFTWARE
K913339 · DSI
Cardiovascular · 166d
Cleared Aug 19, 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · DSH
Cardiovascular · 151d
Cleared Jul 10, 1991
HORIZON XL
K911616 · DRT
Cardiovascular · 90d
Cleared Mar 01, 1991
HORIZON 2000 ST ANALYSIS OPTION
K903524 · DPS
Cardiovascular · 207d
Cleared Jun 22, 1989
HORIZON CENTRAL STATION
K892066 · DRT
Cardiovascular · 84d
Cleared May 31, 1989
HORIZON DISPLAY CONTROLLER PART # 266-200-010
K884423 · DXJ
Cardiovascular · 224d
Cleared Apr 19, 1989
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204 · DSI
Cardiovascular · 121d
Cleared Mar 09, 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · DSF
Cardiovascular · 106d
Cleared Jul 12, 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · DSI
Cardiovascular · 109d
Cleared May 31, 1988
HORIZON 9000
K875167 · DXG
Cardiovascular · 167d
Cleared May 06, 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · DPS
Cardiovascular · 85d
Cleared Mar 16, 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · DPS
Cardiovascular · 96d
Cleared Jun 02, 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · DXN
Cardiovascular · 174d
Cleared Apr 25, 1985
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · DSK
Cardiovascular · 52d
Cleared Apr 25, 1985
HORIZON 1000 CARDIAC MONITOR
K850880 · DRT
Cardiovascular · 52d
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