The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Comfort Twin Nasal Mask.
| Device ID | K091843 |
| 510k Number | K091843 |
| Device Name: | COMFORT TWIN NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko 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 | 2009-06-22 |
| Decision Date | 2009-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959020573 | K091843 | 000 |
| 00606959001329 | K091843 | 000 |
| 00606959001312 | K091843 | 000 |
| 00606959001305 | K091843 | 000 |
| 00606959001299 | K091843 | 000 |
| 00606959027879 | K091843 | 000 |
| 00606959027862 | K091843 | 000 |
| 00606959027855 | K091843 | 000 |
| 00606959027848 | K091843 | 000 |
| 00606959003941 | K091843 | 000 |
| 00606959003958 | K091843 | 000 |
| 00606959012844 | K091843 | 000 |
| 00606959004023 | K091843 | 000 |
| 00606959004016 | K091843 | 000 |
| 00606959004009 | K091843 | 000 |
| 00606959003996 | K091843 | 000 |
| 00606959003989 | K091843 | 000 |
| 00606959003972 | K091843 | 000 |
| 00606959003965 | K091843 | 000 |
| 00606959027831 | K091843 | 000 |