BIPAP Autosv Advanced
FDA 510(k) K090539 · Respironics Inc., Sleep & Home Respiratory Group
510(k) numberK090539
Submission
- Device name
- BIPAP Autosv Advanced
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
Murrysville, PA, US - Received
- February 27, 2009
- Decision date
- October 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNS – Ventilator, Continuous, Non-Life-Supporting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
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| K161492 | Juno VPAP ST-AMNS · Traditional | Resmed, Ltd. | 01/19/2017SE |
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| K153061 | Juno VPAP ST-AMNS · Traditional | Resmed, Ltd. | 04/13/2016SE |
More from Resmed, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K092835 | Comfortgel Nasal MaskBZD · Traditional | 02/12/2010SE |
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| K091191 | Gas TransfillCAW · Traditional | 10/23/2009SE |
| K091843 | Comfort Twin Nasal MaskBZD · Traditional | 09/10/2009SE |
| K091066 | Comfort Twin Nasal MaskBZD · Traditional | 09/03/2009SE |
| K091319 | Remstar Auto A-FlexBZD · Traditional | 08/03/2009SE |
| K090484 | Alice PDXMNR · Traditional | 06/26/2009SE |
| K091271 | Respironics Performax Total Face MaskBZD · Special | 05/29/2009SE |
| K090243 | Remstar M-Series Auto with Aflex CPAP SystemBZD · Special | 05/08/2009SE |
| K083526 | Trilogy 100 VentilatorCBK · Abbreviated | 03/13/2009SE |
Questions and answers
When was BIPAP Autosv Advanced cleared by the FDA?
BIPAP Autosv Advanced (K090539) received a 510(k) decision of Substantially Equivalent on October 30, 2009, 245 days after the submission was received.
What is the product code of K090539?
The FDA product code is MNS – Ventilator, Continuous, Non-Life-Supporting, a Class II (moderate risk) device regulated under 21 CFR 868.5895.