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. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Nov 17, 1995

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL...

Cardiovascular · 59d

Cleared Sep 21, 1994

LIONHEART 3 MULTI-PARAMETER SIMULATOR

Cardiovascular · 21d

Cleared Oct 09, 1992

Cardiovascular · 217d

Cleared Jun 19, 1991

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

Cardiovascular · 295d

Cleared Mar 18, 1991

DEFIBRILLATOR ANALYZER MODEL QED-5

Cardiovascular · 188d

Cleared Dec 05, 1989

ECG SIMULATOR MODEL ECGPLUS

Cardiovascular · 204d

Cleared Aug 06, 1986

Cardiovascular · 47d