Medical Device Manufacturer · US , Mchenry , IL

Bio-Tek Instruments, Inc. - FDA 510(k) Cleared Devices

37 submissions · 35 cleared · Since 1980

37

Total

35

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio-Tek Instruments, Inc. Anesthesiology ✕

5 devices

1-5 of 5

Cleared Oct 08, 1997

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

Anesthesiology · 184d

Cleared Sep 01, 1994

INDEX SPO2 SIMULATOR

Anesthesiology · 408d

Cleared Dec 03, 1985

ADULT VENTILATOR TESTER VT-1

Anesthesiology · 85d

Cleared Sep 12, 1983

BIO-TEK PERCENT OXYGEN MONITOR 74222

Anesthesiology · 123d

Cleared Feb 27, 1981

Anesthesiology · 16d