Medical Device Manufacturer · US , Waukesha , WI

Bci Intl., Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1994

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bci Intl., Inc. Anesthesiology ✕

14 devices

1-14 of 14

Cleared Jun 09, 1999

CAPNOCHECK II, MODEL 8400

Anesthesiology · 70d

Cleared Jun 09, 1999

3402 HANDHELD PULSE OXIMETER

Anesthesiology · 48d

Cleared Aug 20, 1998

Anesthesiology · 79d

Cleared Mar 25, 1998

BCI 3401 HANDHELD PULSE OXIMETER

Anesthesiology · 29d

Cleared Apr 18, 1997

CAPNOCHECK PLUS

Anesthesiology · 87d

Cleared Nov 26, 1996

Anesthesiology · 84d

Cleared Aug 28, 1996

3304 PULSE OXIMETER

Anesthesiology · 85d

Cleared May 15, 1996

OXITEMP, 3301T SA

Anesthesiology · 134d

Cleared Sep 21, 1995

OXILINK (SMALL, MEDIUM, LARGE)

Anesthesiology · 78d

Cleared Jul 17, 1995

Anesthesiology · 236d

Cleared Mar 17, 1995

Anesthesiology · 87d

Cleared Nov 21, 1994

9100 MUTIGAS MONITOR

Anesthesiology · 213d

Cleared Oct 13, 1994

3301 PULSE OXIMETER

Anesthesiology · 91d

Cleared Jun 22, 1994

Anesthesiology · 97d