Product code MNS
- Device name
- Ventilator, Continuous, Non-Life-Supporting
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5895
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251889 | myAir | Resmed Corp | 2026-04-08 |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026-03-17 |
| K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | 2026-02-23 |
| K240778 | Vivo 1, Vivo 2 | Breas Medical AB | 2024-12-13 |
| K231064 | ReddyPort Elbow | Smd Manufacturing, LLC | 2023-07-13 |
| K213169 | BPAP System | BMC Medical Co., Ltd. | 2022-12-05 |
| K171827 | ReddyPort NIV Access Elbow | Smd Manufacturing, LLC | 2018-01-19 |
| K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017-01-19 |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | 2016-09-09 |
| K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016-04-13 |
| K132371 | EASYCARE ONLINE | Resmed, Ltd. | 2013-11-22 |
| K123511 | S9 VPAP TX | Resmed, Ltd. | 2013-03-21 |
| K123557 | EASYCARE ONLINE | Resmed, Ltd. | 2013-03-14 |
| K122324 | VPAP S-A | Resmed, Ltd. | 2012-11-13 |
| K113714 | VPAP TX | Resmed, Ltd. | 2012-05-25 |
| K113288 | VPAP ST-A | Resmed, Ltd. | 2012-03-29 |
| K113815 | RESSCAN | Resmed, Ltd. | 2012-03-27 |
| K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-02-01 |
| K112914 | VPAP TX | Resmed, Ltd. | 2011-12-29 |
| K111378 | OXIMETRY INTERFACE KIT | Philips Respironics, Inc. | 2011-10-04 |
| K102465 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2011-03-24 |
| K101130 | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK | Respironics, Inc. | 2010-09-02 |
| K093731 | VPAP III ST-A | Resmed, Ltd. | 2010-03-22 |
| K093070 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES | Sunrise Medical | 2010-01-26 |
| K092818 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2010-01-22 |
| K092186 | VPAP TX | Resmed, Ltd. | 2009-12-22 |
| K090539 | BIPAP AUTOSV ADVANCED | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-30 |
| K092043 | BIPAP SYNCHRONY 2 | Respironics, Inc. | 2009-08-05 |
| K090248 | BIPAP AUTOSV | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-04 |
| K071509 | BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2007-08-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08401934313396 | ResScan | RESMED CORP. | 2023-02-24 |
| 08401934313389 | ResScan | RESMED CORP. | 2023-02-24 |
| 00606959006225 | BiPAP autoSV Advanced System One 60 Series | Respironics, Inc. | 2016-08-25 |
| 00606959012196 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959012066 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959012042 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959012035 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959012028 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959012011 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959008137 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959008120 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959008113 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959008106 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959008090 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959008083 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007505 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007499 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007482 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007383 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007376 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007369 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007321 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007314 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959007307 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959004603 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959004597 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959004580 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959004573 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959004566 | AF531 | Respironics, Inc. | 2016-06-10 |
| 00606959004559 | AF531 | Respironics, Inc. | 2016-06-10 |