The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Comfortlite Nasal Mask.
| Device ID | K082558 |
| 510k Number | K082558 |
| Device Name: | COMFORTLITE NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Andrew Zeltwanger |
| Correspondent | Andrew Zeltwanger 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 | 2008-09-04 |
| Decision Date | 2009-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959012820 | K082558 | 000 |
| 00606959038165 | K082558 | 000 |
| 00606959038172 | K082558 | 000 |
| 00606959038189 | K082558 | 000 |
| 00606959001411 | K082558 | 000 |
| 00606959001428 | K082558 | 000 |
| 00606959001435 | K082558 | 000 |
| 00606959001442 | K082558 | 000 |
| 00606959001459 | K082558 | 000 |
| 00606959003606 | K082558 | 000 |
| 00606959003613 | K082558 | 000 |
| 00606959003620 | K082558 | 000 |
| 00606959003637 | K082558 | 000 |
| 00606959038158 | K082558 | 000 |