FDA 510(k) Applications Submitted by NELLCOR PURITAN BENNETT, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K014121 12/17/2001 WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 NELLCOR PURITAN BENNETT, INC.
K964543 11/13/1996 INFRASONICS ADULT VENTILATOR TRENDING OPTION NELLCOR PURITAN BENNETT, INC.
K002686 08/28/2000 ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E NELLCOR PURITAN BENNETT, INC.
K990177 01/19/1999 NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR NELLCOR PURITAN BENNETT, INC.
K961450 04/15/1996 SCORE SOFTWARE NELLCOR PURITAN BENNETT, INC.
K972248 06/16/1997 NELLCOR PURITAN BENNETT GEMINI NELLCOR PURITAN BENNETT, INC.
K962516 06/27/1996 TAP ANTI-SNORING DEVICE NELLCOR PURITAN BENNETT, INC.
K964019 10/07/1996 MORPHEE PLUS ALPHA NELLCOR PURITAN BENNETT, INC.
K964516 11/05/1996 TAP NELLCOR PURITAN BENNETT, INC.
K964494 11/08/1996 SLEEPWIZARD NELLCOR PURITAN BENNETT, INC.
K990565 02/22/1999 SUZANNE NELLCOR PURITAN BENNETT, INC.
K980441 02/04/1998 SPIROMETER MODEL NPB-500 NELLCOR PURITAN BENNETT, INC.
K955642 12/12/1995 NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER NELLCOR PURITAN BENNETT, INC.
K963400 08/29/1996 NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER NELLCOR PURITAN BENNETT, INC.
K991823 05/28/1999 N-395 PULSE OXIMETER, MODEL N-395 NELLCOR PURITAN BENNETT, INC.
K983274 09/17/1998 STARTRACK INFANT GRAPHICS MONITOR NELLCOR PURITAN BENNETT, INC.
K993637 10/28/1999 N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS NELLCOR PURITAN BENNETT, INC.
K963707 09/16/1996 NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) NELLCOR PURITAN BENNETT, INC.
K020357 02/04/2002 800 SERIES EASYNEB NEBULIZER NELLCOR PURITAN BENNETT, INC.
K020604 02/25/2002 WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 NELLCOR PURITAN BENNETT, INC.
K030787 03/12/2003 SHILEY FLEXTRA TRACHEOSTOMY TUBE NELLCOR PURITAN BENNETT, INC.
K030930 03/25/2003 OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N NELLCOR PURITAN BENNETT, INC.
K021089 04/04/2002 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR NELLCOR PURITAN BENNETT, INC.
K021090 04/04/2002 OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER NELLCOR PURITAN BENNETT, INC.
K022819 08/26/2002 NELLCOR N-200 PULSE OXIMETER, MODEL N-200 NELLCOR PURITAN BENNETT, INC.
K023494 10/18/2002 NELLCOR INDGO MANUAL RESUSCITATOR NELLCOR PURITAN BENNETT, INC.
K050072 01/12/2005 GOODKNIGHT 425ST NELLCOR PURITAN BENNETT, INC.
K070408 02/12/2007 DURAMAX REUSABLE OXIMETRY SENSOR NELLCOR PURITAN BENNETT, INC.
K051271 05/17/2005 OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR NELLCOR PURITAN BENNETT, INC.
K033973 12/22/2003 OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR NELLCOR PURITAN BENNETT, INC.
K060576 03/06/2006 NELLCOR OXIMAX N-600X PULSE OXIMETER NELLCOR PURITAN BENNETT, INC.
K052186 08/11/2005 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P NELLCOR PURITAN BENNETT, INC.
K971946 05/27/1997 NPB-190 PULSE OXIMETER (NPB-190) NELLCOR PURITAN BENNETT, INC.
K972468 07/01/1997 NPB-195 PULSE OXIMETER NELLCOR PURITAN BENNETT, INC.
K972837 07/31/1997 NPB-290 PULSE OXIMETER (NPB-290) NELLCOR PURITAN BENNETT, INC.
K973147 08/22/1997 NPB-295 PULSE OXIMETER NELLCOR PURITAN BENNETT, INC.
K012891 08/28/2001 OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) NELLCOR PURITAN BENNETT, INC.
K051352 05/24/2005 OXIMAX NPB-40 HANDHELD PULSE OXIMETER NELLCOR PURITAN BENNETT, INC.
K960468 02/01/1996 DMR/CO2 COMBO KTI NELLCOR PURITAN BENNETT, INC.
K982728 08/05/1998 NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C NELLCOR PURITAN BENNETT, INC.
K973419 09/10/1997 DMR PLUS DISPOSABLE MANUAL RESUSCITATOR NELLCOR PURITAN BENNETT, INC.
K980365 01/29/1998 GOODKNIGHT 418 CPAP SYSTEM NELLCOR PURITAN BENNETT, INC.


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