| 2026-05-07 |
K253647 |
Draegerwerk AG & CO Kgaa
|
Evita (V800); Evita (V600) |
| 2026-04-14 |
K252663 |
Iconic Solutions by Murcia, SL
|
Inbentus Versatile |
| 2026-03-12 |
K251888 |
Hsiner Co., Ltd.
|
VPAP Pediatric Face Mask |
| 2025-12-19 |
K232365 |
Oconnell Regulatory Consultants, Inc.
|
Vivo 45 LS |
| 2025-09-10 |
K252173 |
Fisher & Paykel Healthcare, Ltd.
|
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full |
| 2025-08-28 |
K243767 |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
|
SV600, SV800 Ventilator |
| 2025-05-08 |
K251133 |
Telesair, Inc.
|
AVEA disposable expiratory filter/water trap (11790) |
| 2024-12-30 |
K243394 |
Respironics, Inc.
|
AF531 Oro-Nasal SE Face Mask |
| 2024-12-13 |
K233486 |
ZOLL Medical Corporation
|
731 Series Ventilator |
| 2024-12-02 |
K223120 |
Flight Medical Innovations , Ltd.
|
Ventoux VC2; Ventoux VC3 |
| 2024-11-13 |
K241135 |
Corvent Medical, Inc.
|
RESPOND(R) Ventilator |
| 2024-08-28 |
K241943 |
Sleepnet Corporation
|
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask |
| 2024-08-14 |
K232836 |
Dimar S.P.A.
|
Family of DIMAR DMAX NIV masks |
| 2024-08-13 |
K240807 |
Ventis Medical, Inc.
|
VM-2000 |
| 2024-06-27 |
K241520 |
Sleepnet Corporation
|
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask |
| 2024-03-01 |
K231778 |
Nihon Kohden Orangemed, LLC
|
Nihon Kohden NKV-550 Series Ventilator System |
| 2023-07-20 |
K213098 |
Origin Medical Devices
|
Panther 5 |
| 2023-06-16 |
K220107 |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
|
Mindray SV600 Ventilator, Mindray SV800 Ventilator |
| 2023-05-31 |
K222644 |
Nihon Kohden Orangemed, Inc.
|
Nihon Kohden NKV-440 Ventilator System |
| 2023-05-16 |
K222207 |
Draegerwerk AG & CO Kgaa
|
Babylog VN800, Babylog VN600 |
| 2023-05-16 |
K222024 |
Draegerwerk AG & CO Kgaa
|
Evita V800, Evita V600 |
| 2021-11-10 |
K201082 |
Vyaire Medical, Inc.
|
LTV2 Series Ventilators |
| 2021-11-04 |
K210384 |
Datex-Ohmeda, Inc.
|
CARESCAPE R860 |
| 2021-04-20 |
K201874 |
Maquet Critical Care AB
|
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 |
| 2021-04-14 |
K203449 |
Fisher & Paykel Healthcare, Ltd.
|
F&P Visairo NIV Mask Range |