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 |
| K240779 | Breas Medical AB | Vivo 3 | 12/13/2024 |
| K191624 | Fisher & Paykel Healthcare Limited | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | 03/09/2020 |
| K233643 | Fisher & Paykel Healthcare Ltd | F&P Airvo 3 NIV (PT311US) | 08/09/2024 |
| 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 |
| K242931 | MEKICS Co., Ltd. | HFT750U | 05/15/2025 |
| 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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