Medical Device Manufacturer · US , Walker , MI

Datex Division Instrumentarium Corp.

55 submissions · 55 cleared · Since 1982
55
Total
55
Cleared
0
Denied

Datex Division Instrumentarium Corp. — FDA 510(k) Submissions

Datex Division Instrumentarium Corp. has submitted 55 FDA 510(k) premarket notifications since 1982, of which 55 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Oximeter, Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration), Electrocardiograph, Gas-machine, Anesthesia . Use the specialty filter in the sidebar to narrow results.

55 devices
1–25 of 55
AS/3 ESTPR MODULE
K953175 · MLD Monitor, St Segment With... · Cardiovascular
Feb 1997 580d
AS/3 LIGHT MONITOR
K961247 · DPS Electrocardiograph · Cardiovascular
Oct 1996 205d
AS/3 AIRWAY MODULE
K943458 · CBS Analyzer, Gas, Halothane,... · Anesthesiology
Feb 1995 211d
AS/3 MEMORY MODULE, M0MEM
K945234 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jan 1995 92d
DATEX AS/3 PATIENT MONITOR
K933156 · DPS Electrocardiograph · Cardiovascular
Dec 1994 549d
DATEX AS/3 TM ANAESTHESIA MONITOR
K933285 · BSZ Gas-machine, Anesthesia · Anesthesiology
Nov 1994 496d
AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
K943456 · DQA Oximeter · Anesthesiology
Oct 1994 91d
ANAESTHESIA RECORD KEEPER
K923172 · BSZ Gas-machine, Anesthesia · Anesthesiology
Aug 1994 771d
AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD
K935477 · CCK Analyzer, Gas,... · Anesthesiology
Aug 1994 259d
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · DSK Computer, Blood-pressure · Cardiovascular
Jul 1994 9d
AS/3 TM NETWORK
K933284 · CCK Analyzer, Gas,... · Anesthesiology
Jul 1994 370d
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K932098 · BZK Spirometer, Monitoring... · Anesthesiology
Nov 1993 210d
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · BZL Computer, Oxygen-uptake · Anesthesiology
Nov 1993 247d
AS/3 COP MODULE
K922876 · CBQ Analyzer, Gas, Enflurane,... · Anesthesiology
Jul 1993 401d
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K923276 · CBQ Analyzer, Gas, Enflurane,... · Anesthesiology
Jul 1993 380d
NGM FRAME
K911644 · CBQ Analyzer, Gas, Enflurane,... · Anesthesiology
Mar 1992 324d
NGM NIBP MODULE
K911645 · DXN System, Measurement,... · Cardiovascular
Mar 1992 324d
NGM ESTP MODULE
K911646 · MHX Monitor, Physiological,... · Cardiovascular
Feb 1992 312d
NGM GAS MODULE
K911647 · CBQ Analyzer, Gas, Enflurane,... · Anesthesiology
Sep 1991 157d
CARDIOCAP CMX-104 MONITOR
K903237 · DXN System, Measurement,... · Cardiovascular
Jul 1991 359d
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K905754 · CBS Analyzer, Gas, Halothane,... · Anesthesiology
Jun 1991 175d
SATLITE PLUS PULSE OXIMETER
K905140 · DQA Oximeter · Anesthesiology
May 1991 194d
CARDIOCAP DR-124 RECORDER
K910620 · DRG Transmitters And... · Cardiovascular
May 1991 84d
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR
K903104 · CBQ Analyzer, Gas, Enflurane,... · Anesthesiology
Jan 1991 194d
CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR
K896652 · CCK Analyzer, Gas,... · Anesthesiology
Sep 1990 285d
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