Medical Device Manufacturer · US , Walker , MI

Datex Division Instrumentarium Corp. - FDA 510(k) Cleared Devices

55 submissions · 55 cleared · Since 1982
55
Total
55
Cleared
0
Denied
FDA 510(k) Regulatory Record - Datex Division Instrumentarium Corp. Cardiovascular
18 devices
1-18 of 18
Cleared Feb 06, 1997
AS/3 ESTPR MODULE
K953175 · MLD
Cardiovascular · 580d
Cleared Oct 23, 1996
AS/3 LIGHT MONITOR
K961247 · DPS
Cardiovascular · 205d
Cleared Dec 30, 1994
DATEX AS/3 PATIENT MONITOR
K933156 · DPS
Cardiovascular · 549d
Cleared Jul 27, 1994
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · DSK
Cardiovascular · 9d
Cleared Mar 04, 1992
NGM NIBP MODULE
K911645 · DXN
Cardiovascular · 324d
Cleared Feb 21, 1992
NGM ESTP MODULE
K911646 · MHX
Cardiovascular · 312d
Cleared Jul 17, 1991
CARDIOCAP CMX-104 MONITOR
K903237 · DXN
Cardiovascular · 359d
Cleared May 07, 1991
CARDIOCAP DR-124 RECORDER
K910620 · DRG
Cardiovascular · 84d
Cleared Jul 06, 1990
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
K902492 · DRI
Cardiovascular · 31d
Cleared Jul 06, 1990
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
K902493 · DRI
Cardiovascular · 31d
Cleared Mar 08, 1990
CARDIOCAP(TM) CMX-104 MONITOR
K896190 · DPS
Cardiovascular · 133d
Cleared Mar 06, 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · DRT
Cardiovascular · 75d
Cleared Jul 14, 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · DSF
Cardiovascular · 219d
Cleared Dec 28, 1988
CARDIOCAP(TM) CM-104 MONITOR
K884955 · DXN
Cardiovascular · 29d
Cleared Dec 27, 1988
CARDIOCAP(TM) CTO-104 MONITOR
K884956 · DPS
Cardiovascular · 28d
Cleared Jul 28, 1988
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · DSK
Cardiovascular · 70d
Cleared Sep 24, 1986
MODIFIED CARDIOCAP MONITOR
K862455 · DSK
Cardiovascular · 89d
Cleared Apr 06, 1984
ABM ANESTHESIA & BRAIN MONITOR
K840232
Cardiovascular · 87d
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