Medical Device Manufacturer · US , Mchenry , IL

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

13 submissions · 13 cleared · Since 1979

13

Total

13

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Aug 19, 2003

ADVISOR, MODEL 9200

Anesthesiology · 193d

Cleared Aug 18, 2003

BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER

Anesthesiology · 75d

Cleared Jun 03, 2002

BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR

Anesthesiology · 89d

Cleared Apr 30, 2002

BCI 3180 PULSE OXIMETER

Anesthesiology · 85d

Cleared Feb 21, 2002

BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

Anesthesiology · 92d

Cleared Jan 03, 2002

3420 DIGIT PULSE OXIMETER, MODEL 3420

Anesthesiology · 101d

Cleared Jun 14, 2001

BCI 3403 SLEEP SCREENING PULSE OXIMETER

Anesthesiology · 59d

Cleared Jul 05, 2000

BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A

Anesthesiology · 23d

Cleared Oct 17, 1994

Anesthesiology · 175d