FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K090113 |
BREAS MEDICAL AB |
BREAS VIVO 40 SYSTEM |
05/14/2009 |
K053607 |
BREAS MEDICAL AB |
BREAS VIVO 40 SYSTEM |
03/16/2006 |
K071702 |
BREAS MEDICAL AB |
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 |
02/15/2008 |
K191624 |
Fisher & Paykel Healthcare Limited |
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version |
03/09/2020 |
K060044 |
FISHER & PAYKEL HEALTHCARE, LTD. |
ACUTE CARE FACE MASK, MODEL RT040 |
04/06/2006 |
K170367 |
Fisher and Paykel Healthcare Limited |
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo |
08/24/2017 |
K003075 |
MALLINCKRODT, INC. |
KNIGHTSTAR 330 VENTILATOR |
12/11/2001 |
K230173 |
Maquet Critical Care AB |
Servo-air Lite Ventilator System |
07/06/2023 |
K213521 |
Nihon Kohden OrangeMed, Inc. |
Nihon Kohden NKV-330 Ventilator System |
07/01/2022 |
K973004 |
PURITAN BENNETT CORP. |
KNIGHTSTAR 335 |
07/16/1998 |
K113640 |
RESMED GERMANY INC. |
STELLAR 150 |
04/05/2012 |
K122715 |
RESMED GERMANY INC. |
STELLAR 150 |
06/17/2013 |
K103167 |
RESMED GERMANY INC. |
STELLAR 150 |
03/01/2011 |
K974539 |
RESMED LTD. |
SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM |
08/06/1998 |
K082660 |
RESPIRONICS CALIFORNIA, INC. |
V60 VENTILATOR, MODEL V8000 |
01/09/2009 |
K102985 |
Respironics Inc. |
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS |
04/05/2011 |
K121623 |
RESPIRONICS, INC. |
BIPAP A 40 VENTILATORY SUPPORT SYSTEM |
12/14/2012 |
K951264 |
RESPIRONICS, INC. |
BIPAP MODEL S/T-D |
07/29/1996 |
K955324 |
RESPIRONICS, INC. |
BIPAP S/T-D 30 SYSTEM |
12/20/1996 |
K982454 |
RESPIRONICS, INC. |
BIPAP VISION VENTILATORY SUPPORT |
11/03/1998 |
K990574 |
RESPIRONICS, INC. |
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 |
05/24/1999 |