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
55 devices
26-50 of 55
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 Nov 29, 1989
OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER
K895780 · CCK
Anesthesiology · 63d
Cleared Aug 02, 1989
CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR
K891076 · CCK
Anesthesiology · 155d
Cleared Jul 14, 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · DSF
Cardiovascular · 219d
Cleared Jun 06, 1989
CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
K884991 · BSZ
Anesthesiology · 187d
Cleared Mar 22, 1989
SATLITE TRANS PORTABLE PULSE OXIMETER
K890753 · DQA
Anesthesiology · 37d
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 Oct 28, 1988
BM-103 BATTERY MODULE
K883877 · DQA
Anesthesiology · 45d
Cleared Oct 19, 1988
NORMOCAP 200 CAPNOMETER
K882748 · CCK
Anesthesiology · 106d
Cleared Oct 19, 1988
DATEX AIRWAY MONITOR
K882885 · CCK
Anesthesiology · 100d
Cleared Jul 28, 1988
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · DSK
Cardiovascular · 70d
Cleared Jul 18, 1988
SATLITE+/PB251+ PULSE OXIMETER
K881883 · DQA
Anesthesiology · 75d
Cleared Dec 29, 1987
CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104
K873859 · DQA
Anesthesiology · 98d
Cleared Sep 14, 1987
OSCAR(TM) PB255 OXIMETER CAPNOMETER
K872760 · CCK
Anesthesiology · 63d
Cleared Jun 29, 1987
PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE
K871826 · DQA
Anesthesiology · 49d
Cleared Mar 20, 1987
SATLITE/PB251 PULSE OXIMETER
K870621 · DQA
Anesthesiology · 36d
Cleared Mar 17, 1987
DELTATRAC(TM) METABOLIC MONITOR
K864603 · BZL
Anesthesiology · 113d
Cleared Sep 24, 1986
MODIFIED CARDIOCAP MONITOR
K862455 · DSK
Cardiovascular · 89d
Cleared Sep 03, 1986
PB GRAPHICS PRINTER AND PB VIDEO DISPLAY
K863248 · CBQ
Anesthesiology · 12d
Cleared May 02, 1986
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
K861474 · CBQ
Anesthesiology · 10d
Cleared Apr 04, 1986
PB 254 IR - SPECTROMETER
K861213 · CCK
Anesthesiology · 4d
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