Medical Device Manufacturer · US , Mchenry , IL

Biochem International, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1977

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biochem International, Inc. Anesthesiology ✕

21 devices

1-12 of 21

Cleared Apr 11, 1994

BIOCHEM MODEL 3302 NEWOX2 OXIMETER

Anesthesiology · 825d

Cleared Dec 03, 1993

8100 ANESTHETIC AGENT MONITOR

Anesthesiology · 200d

Cleared Jan 07, 1993

BIOCHEM MODEL 3301 NEWOX1 OXIMETER

Anesthesiology · 366d

Cleared Aug 22, 1991

BIOCHEM TEMPERATURE/ FIO2 MODULE

Anesthesiology · 205d

Cleared Jul 27, 1990

BIOCHEM 9100 MULTIGAS MONITOR

Anesthesiology · 93d

Cleared Aug 31, 1989

BIOCHEM 8100 ANESTHETIC AGENT MONITOR

Anesthesiology · 141d

Cleared Jun 15, 1989

BIOCHEM 520 BREATH INDICATOR

Anesthesiology · 114d

Cleared Dec 17, 1987

BIOCHEM 9090 CAPNOGRAPH/SAO2

Anesthesiology · 86d

Cleared Dec 11, 1987

BIOCHEM 8800 CAPNOMETER

Anesthesiology · 74d

Cleared Apr 21, 1987

BIOCHEM 8090 CAPNOGRAPH

Anesthesiology · 32d

Cleared Mar 03, 1987

BIOCHEM MICROSPAN 1040 OXIMETER

Anesthesiology · 48d

Cleared Nov 07, 1986

BIOCHEM CO/OX 1000

Anesthesiology · 80d