Medical Device Manufacturer · US , Waukesha , WI

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

20 submissions · 20 cleared · Since 1994

Recent clearances: CAPNOCHECK II, MODEL 8400, 3402 HANDHELD PULSE OXIMETER, BCI MINI-TORR PLUS, MODEL 6004

20

Total

20

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Mar 25, 1999

BCI MINI-TORR PLUS, MODEL 6004

Cardiovascular · 86d

Cleared Jan 22, 1999

6004 NIBP MONITOR WITH TEMPERATURE

Cardiovascular · 87d

Cleared Sep 25, 1998

VITAL SIGNS MONITOR

Cardiovascular · 87d

Cleared Mar 11, 1998

REUSABLE FINGER SENSOR 3444

Cardiovascular · 85d

Cleared Nov 12, 1997

BCI MODEL 6004 NIBP MONITOR (6004)

Cardiovascular · 253d

Cleared Oct 19, 1995

6200 VITAL SIGNS MONITOR

Cardiovascular · 91d