The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Comfortgel Full Face Mask.
| Device ID | K073600 |
| 510k Number | K073600 |
| Device Name: | COMFORTGEL FULL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita T Yurkos |
| Correspondent | Zita T Yurkos RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-21 |
| Decision Date | 2008-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959022287 | K073600 | 000 |
| 00606959006553 | K073600 | 000 |
| 00606959006546 | K073600 | 000 |
| 00606959006539 | K073600 | 000 |
| 00606959043909 | K073600 | 000 |
| 00606959043893 | K073600 | 000 |
| 00606959043886 | K073600 | 000 |
| 00606959043879 | K073600 | 000 |
| 30606959034366 | K073600 | 000 |
| 30606959034359 | K073600 | 000 |
| 00606959006560 | K073600 | 000 |
| 00606959007642 | K073600 | 000 |
| 00606959022270 | K073600 | 000 |
| 00606959022263 | K073600 | 000 |
| 00606959022256 | K073600 | 000 |
| 00606959021044 | K073600 | 000 |
| 00606959021037 | K073600 | 000 |
| 00606959021020 | K073600 | 000 |
| 00606959013889 | K073600 | 000 |
| 00606959008076 | K073600 | 000 |
| 00606959007659 | K073600 | 000 |
| 30606959034342 | K073600 | 000 |