FDA 510(k) Applications for Medical Device Product Code "MNS"
(Ventilator, Continuous, Non-Life-Supporting)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K213169 | BMC Medical Co., Ltd. | BPAP System | 12/05/2022 |
| K060546 | BREAS MEDICAL AB | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 | 05/26/2006 |
| K962517 | HEALTHDYNE TECHNOLOGIES, INC. | MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV | 02/20/1997 |
| K031896 | INNOMED TECHNOLOGIES | NASAL-AIR CRITICAL CARE | 01/14/2004 |
| K111378 | PHILIPS RESPIRONICS, INC | OXIMETRY INTERFACE KIT | 10/04/2011 |
| K942210 | PURITAN BENNETT CORP. | PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM | 02/09/1996 |
| K974417 | RESMED CORP. | SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM | 06/24/1998 |
| K153061 | RESMED LTD | Juno VPAP ST-A | 04/13/2016 |
| K161492 | ResMed Ltd | Juno VPAP ST-A | 01/19/2017 |
| K161487 | ResMed Ltd | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | 09/09/2016 |
| K123557 | RESMED LTD. | EASYCARE ONLINE | 03/14/2013 |
| K132371 | RESMED LTD. | EASYCARE ONLINE | 11/22/2013 |
| K113815 | RESMED LTD. | RESSCAN | 03/27/2012 |
| K123511 | RESMED LTD. | S9 VPAP TX | 03/21/2013 |
| K051364 | RESMED LTD. | VPAP ADAPT | 08/16/2005 |
| K033276 | RESMED LTD. | VPAP III ST-A | 06/07/2004 |
| K093731 | RESMED LTD. | VPAP III ST-A | 03/22/2010 |
| K060105 | RESMED LTD. | VPAP III ST-A/KIDSTA MASK SYSTEM | 04/07/2006 |
| K122324 | RESMED LTD. | VPAP S-A | 11/13/2012 |
| K113288 | RESMED LTD. | VPAP ST-A | 03/29/2012 |
| K092186 | RESMED LTD. | VPAP TX | 12/22/2009 |
| K112914 | RESMED LTD. | VPAP TX | 12/29/2011 |
| K113714 | RESMED LTD. | VPAP TX | 05/25/2012 |
| K053168 | RESPIRONICS (IRELAND) LIMITED | BIPAP FOCUS | 01/04/2006 |
| K090248 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | BIPAP AUTOSV | 03/04/2009 |
| K090539 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | BIPAP AUTOSV ADVANCED | 10/30/2009 |
| K071509 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM | 08/08/2007 |
| K070328 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | BIPAP SYNCHRONY WITH AVAPS | 05/08/2007 |
| K113053 | RESPIRONICS, INC. | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | 02/01/2012 |
| K063540 | RESPIRONICS, INC. | BIPAP AUTOSV | 02/22/2007 |
| K092818 | RESPIRONICS, INC. | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | 01/22/2010 |
| K102465 | RESPIRONICS, INC. | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | 03/24/2011 |
| K984407 | RESPIRONICS, INC. | BIPAP HARMONY S/T, MODEL 1001445 | 05/19/1999 |
| K031656 | RESPIRONICS, INC. | BIPAP HARMONY VENTILATORY SUPPORT SYSTEM | 07/30/2003 |
| K063533 | RESPIRONICS, INC. | BIPAP SYNCHRONY | 02/20/2007 |
| K092043 | RESPIRONICS, INC. | BIPAP SYNCHRONY 2 | 08/05/2009 |
| K101130 | RESPIRONICS, INC. | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK | 09/02/2010 |
| K992530 | RESPIRONICS, INC. | BIPAP SYNCHRONY HC | 03/20/2000 |
| K012323 | RESPIRONICS, INC. | BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM | 12/20/2001 |
| K020777 | RESPIRONICS, INC. | BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX | 03/20/2002 |
| K231064 | SMD Manufacturing LLC | ReddyPort Elbow | 07/13/2023 |
| K171827 | SMD Manufacturing, LLC | ReddyPort NIV Access Elbow | 01/19/2018 |
| K093070 | SUNRISE MEDICAL | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES | 01/26/2010 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
