The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Magneto Nasal Mask.
| Device ID | K210386 |
| 510k Number | K210386 |
| Device Name: | Magneto Nasal Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 |
| Contact | Anna Danley |
| Correspondent | Anna Danley Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959060128 | K210386 | 000 |
| 00606959060104 | K210386 | 000 |
| 00606959060098 | K210386 | 000 |
| 00606959060135 | K210386 | 000 |