Bci Intl., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K991086CAPNOCHECK II, MODEL 8400June 9, 1999
K9914103402 HANDHELD PULSE OXIMETERJune 9, 1999
K984618BCI MINI-TORR PLUS, MODEL 6004March 25, 1999
K9837966004 NIBP MONITOR WITH TEMPERATUREJanuary 22, 1999
K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200September 25, 1998
K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITORAugust 20, 1998
K980714BCI 3401 HANDHELD PULSE OXIMETERMarch 25, 1998
K974697REUSABLE FINGER SENSOR 3444March 11, 1998
K970801BCI MODEL 6004 NIBP MONITOR (6004)November 12, 1997
K970209CAPNOCHECK PLUSApril 18, 1997
K963496OXI TEMPNovember 26, 1996
K9621563304 PULSE OXIMETERAugust 28, 1996
K960058OXITEMP, 3301T SAMay 15, 1996
K9534156200 VITAL SIGNS MONITOROctober 19, 1995
K953126OXILINK (SMALL, MEDIUM, LARGE)September 21, 1995
K945754NEWOX2July 17, 1995
K9461853301T OXITEMPMarch 17, 1995
K9419719100 MUTIGAS MONITORNovember 21, 1994
K9434043301 PULSE OXIMETEROctober 13, 1994
K941289PULSE OXIMETERJune 22, 1994