Remstar Auto A-Flex
FDA 510(k) K091319 · Respironics Inc., Sleep & Home Respiratory Group
510(k) numberK091319
Submission
- Device name
- Remstar Auto A-Flex
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
Murrysville, PA, US - Received
- May 5, 2009
- Decision date
- August 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| 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 Remstar Auto A-Flex cleared by the FDA?
Remstar Auto A-Flex (K091319) received a 510(k) decision of Substantially Equivalent on August 3, 2009, 90 days after the submission was received.
What is the product code of K091319?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.