Respironics Performax Se Total Face Mask
FDA 510(k) K092648 · Respironics Inc., Sleep & Home Respiratory Group
510(k) numberK092648
Submission
- Device name
- Respironics Performax Se Total Face Mask
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
Murrysville, PA, US - Received
- August 28, 2009
- Decision date
- December 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K092835 | Comfortgel Nasal MaskBZD · Traditional | 02/12/2010SE |
| K090539 | BIPAP Autosv AdvancedMNS · Traditional | 10/30/2009SE |
| 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 Respironics Performax Se Total Face Mask cleared by the FDA?
Respironics Performax Se Total Face Mask (K092648) received a 510(k) decision of Substantially Equivalent on December 18, 2009, 112 days after the submission was received.
What is the product code of K092648?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.