FDA 510(k) Applications Submitted by DONALD J ALEXANDER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040090 |
01/16/2004 |
COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) |
PNEUPAC LTD. |
| K090205 |
01/28/2009 |
BCI WW1021 PC APPLICATION |
SMITHS MEDICAL PM, INC. |
| K020350 |
02/04/2002 |
BCI 3180 PULSE OXIMETER |
BCI, INC. |
| K030407 |
02/07/2003 |
ADVISOR, MODEL 9200 |
BCI, INC. |
| K030803 |
03/13/2003 |
PARAPAC 200D TRANSPORT, MODEL V200D |
PNEU PAC, LTD. |
| K010770 |
03/14/2001 |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
BCI, INC. |
| K070732 |
03/15/2007 |
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
| K020899 |
03/20/2002 |
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D |
PNEU PAC, LTD. |
| K991086 |
03/31/1999 |
CAPNOCHECK II, MODEL 8400 |
BCI INTL., INC. |
| K011156 |
04/16/2001 |
BCI 3403 SLEEP SCREENING PULSE OXIMETER |
BCI, INC. |
| K991410 |
04/22/1999 |
3402 HANDHELD PULSE OXIMETER |
BCI INTL., INC. |
| K051322 |
05/20/2005 |
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS |
SMITHS MEDICAL INTERNATIONAL, LTD. |
| K071527 |
06/04/2007 |
PNEUPAC VR1 AIR MIX |
SMITHS MEDICAL INTERNATIONAL, LTD. |
| K021841 |
06/05/2002 |
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER |
PNEU PAC, LTD. |
| K001770 |
06/12/2000 |
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A |
BCI, INC. |
| K013171 |
09/24/2001 |
3420 DIGIT PULSE OXIMETER, MODEL 3420 |
BCI, INC. |
| K013862 |
11/21/2001 |
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM |
BCI, INC. |
| K083557 |
12/02/2008 |
BCI WW1030 PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
| K083705 |
12/15/2008 |
BCI WW1020 PULSE OXIMETER, MODEL WW1020 |
SMITHS MEDICAL PM, INC. |
| K043495 |
12/17/2004 |
BABYPAC |
SMITHS MEDICAL INTERNATIONAL LTD., LUTON |
| K083787 |
12/19/2008 |
BCI WW1000 PULSE OXIMETER, MODEL WW1000 |
SMITHS MEDICAL PM, INC. |
| K984618 |
12/29/1998 |
BCI MINI-TORR PLUS, MODEL 6004 |
BCI INTL., INC. |
| K960058 |
01/02/1996 |
OXITEMP, 3301T SA |
BCI INTL., INC. |
| K970209 |
01/21/1997 |
CAPNOCHECK PLUS |
BCI INTL., INC. |
| K980714 |
02/24/1998 |
BCI 3401 HANDHELD PULSE OXIMETER |
BCI INTL., INC. |
| K970801 |
03/04/1997 |
BCI MODEL 6004 NIBP MONITOR (6004) |
BCI INTL., INC. |
| K020739 |
03/06/2002 |
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR |
BCI, INC. |
| K011177 |
04/17/2001 |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
BCI, INC. |
| K981939 |
06/02/1998 |
AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR |
BCI INTL., INC. |
| K962156 |
06/04/1996 |
3304 PULSE OXIMETER |
BCI INTL., INC. |
| K031742 |
06/04/2003 |
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER |
BCI, INC. |
| K982279 |
06/30/1998 |
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 |
BCI INTL., INC. |
| K963496 |
09/03/1996 |
OXI TEMP |
BCI INTL., INC. |
| K983796 |
10/27/1998 |
6004 NIBP MONITOR WITH TEMPERATURE |
BCI INTL., INC. |
| K974697 |
12/16/1997 |
REUSABLE FINGER SENSOR 3444 |
BCI INTL., INC. |
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