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. Cardiovascular ✕

6 devices

1-6 of 6

Cleared May 26, 1993

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE

Cardiovascular · 429d

Cleared Aug 22, 1991

BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

Cardiovascular · 148d

Cleared Sep 04, 1990

BIOCHEM 6100 NON-INVASIVE MONITOR

Cardiovascular · 43d

Cleared Dec 20, 1989

BIOCHEM 3100 OXIMETER

Cardiovascular · 208d

Cleared Aug 20, 1980

NON-INVASIVE, BLOOD PRESSURE MONITOR

Cardiovascular · 30d

Cleared Feb 05, 1980

TRANSCUTANEOUS OXYGEN MONITOR

Cardiovascular · 22d