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

35 devices

26-35 of 35

Cleared Dec 29, 1987

CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104

Anesthesiology · 98d

Cleared Sep 14, 1987

OSCAR(TM) PB255 OXIMETER CAPNOMETER

Anesthesiology · 63d

Cleared Jun 29, 1987

PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE

Anesthesiology · 49d

Cleared Mar 20, 1987

SATLITE/PB251 PULSE OXIMETER

Anesthesiology · 36d

Cleared Mar 17, 1987

DELTATRAC(TM) METABOLIC MONITOR

Anesthesiology · 113d

Cleared Sep 03, 1986

PB GRAPHICS PRINTER AND PB VIDEO DISPLAY

Anesthesiology · 12d

Cleared May 02, 1986

PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT

Anesthesiology · 10d

Cleared Apr 04, 1986

PB 254 IR - SPECTROMETER

Anesthesiology · 4d

Cleared Feb 17, 1984

NEUROMUSCULAR TRANSMISSION MONITOR

Anesthesiology · 38d

Cleared Sep 12, 1983

NORMAC ANESTHETIC AGENT MONITOR

Anesthesiology · 74d