Company · US

Bci Intl., Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1999. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DQA	Oximeter	11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	3
DXN	System, Measurement, Blood-Pressure, Non-Invasive	3
DPS	Electrocardiograph	1
DQH	Cardiograph, Apex (Vibrocardiograph)	1
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	1

Decided	510(k)	Device and applicant	Code
Jun 9, 1999	K991410	3402 HANDHELD PULSE OXIMETER Bci Intl., Inc.	DQA
Jun 9, 1999	K991086	CAPNOCHECK II, MODEL 8400 Bci Intl., Inc.	CCK
Mar 25, 1999	K984618	BCI MINI-TORR PLUS, MODEL 6004 Bci Intl., Inc.	DXN
Jan 22, 1999	K983796	6004 NIBP MONITOR WITH TEMPERATURE Bci Intl., Inc.	DXN
Sep 25, 1998	K982279	VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 Bci Intl., Inc.	MHX
Aug 20, 1998	K981939	AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR Bci Intl., Inc.	DQA
Mar 25, 1998	K980714	BCI 3401 HANDHELD PULSE OXIMETER Bci Intl., Inc.	DQA
Mar 11, 1998	K974697	REUSABLE FINGER SENSOR 3444 Bci Intl., Inc.	DQH
Nov 12, 1997	K970801	BCI MODEL 6004 NIBP MONITOR (6004) Bci Intl., Inc.	DXN
Apr 18, 1997	K970209	CAPNOCHECK PLUS Bci Intl., Inc.	CCK
Nov 26, 1996	K963496	OXI TEMP Bci Intl., Inc.	DQA
Aug 28, 1996	K962156	3304 PULSE OXIMETER Bci Intl., Inc.	DQA
May 15, 1996	K960058	OXITEMP, 3301T SA Bci Intl., Inc.	DQA
Oct 19, 1995	K953415	6200 VITAL SIGNS MONITOR Bci Intl., Inc.	DPS
Sep 21, 1995	K953126	OXILINK (SMALL, MEDIUM, LARGE) Bci Intl., Inc.	DQA
Jul 17, 1995	K945754	NEWOX2 Bci Intl., Inc.	DQA
Mar 17, 1995	K946185	3301T OXITEMP Bci Intl., Inc.	DQA
Nov 21, 1994	K941971	9100 MUTIGAS MONITOR Bci Intl., Inc.	CCK
Oct 13, 1994	K943404	3301 PULSE OXIMETER Bci Intl., Inc.	DQA
Jun 22, 1994	K941289	PULSE OXIMETER Bci Intl., Inc.	DQA

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.