FDA 510(k) Applications for Medical Device Product Code "MNT"
(Ventilator, Continuous, Minimal Ventilatory Support,Facility Use)

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


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