Medical Device Manufacturer · US , Walker , MI

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

55 submissions · 55 cleared · Since 1982

Recent clearances: AS/3 ESTPR MODULE, AS/3 LIGHT MONITOR, AS/3 AIRWAY MODULE

55

Total

55

Cleared

0

Denied

FDA 510(k) Regulatory Record - Datex Division Instrumentarium Corp. Anesthesiology ✕

35 devices

1-12 of 35

Cleared Feb 14, 1995

AS/3 AIRWAY MODULE

Anesthesiology · 211d

Cleared Jan 27, 1995

AS/3 MEMORY MODULE, M0MEM

Anesthesiology · 92d

Cleared Nov 14, 1994

DATEX AS/3 TM ANAESTHESIA MONITOR

Anesthesiology · 496d

Cleared Oct 17, 1994

AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

Anesthesiology · 91d

Cleared Aug 09, 1994

ANAESTHESIA RECORD KEEPER

Anesthesiology · 771d

Cleared Aug 01, 1994

AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD

Anesthesiology · 259d

Cleared Jul 11, 1994

AS/3 TM NETWORK

Anesthesiology · 370d

Cleared Nov 29, 1993

CAPNOMAC ULTIMA ANESTHESIA MONITOR

Anesthesiology · 210d

Cleared Nov 24, 1993

DELTATRAC(TM) II METABOLIC MONITOR

Anesthesiology · 247d

Cleared Jul 21, 1993

AS/3 COP MODULE

Anesthesiology · 401d

Cleared Jul 21, 1993

CAPNOMAC ULTIMA ANESTHESIA MONITOR

Anesthesiology · 380d

Cleared Mar 04, 1992

Anesthesiology · 324d