The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Respironics Performax Se Total Face Mask.
| Device ID | K092648 |
| 510k Number | K092648 |
| Device Name: | RESPIRONICS PERFORMAX SE TOTAL FACE MASK |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY Monroeville, PA 15146 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2009-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959013728 | K092648 | 000 |
| 30606959000880 | K092648 | 000 |
| 00606959007703 | K092648 | 000 |
| 00606959007710 | K092648 | 000 |
| 00606959007727 | K092648 | 000 |
| 30606959011824 | K092648 | 000 |
| 30606959011831 | K092648 | 000 |
| 30606959011862 | K092648 | 000 |
| 30606959011879 | K092648 | 000 |
| 00606959011908 | K092648 | 000 |
| 00606959011915 | K092648 | 000 |
| 00606959011977 | K092648 | 000 |
| 30606959011992 | K092648 | 000 |
| 30606959012999 | K092648 | 000 |
| 30606959013002 | K092648 | 000 |
| 00606959013667 | K092648 | 000 |
| 00606959013711 | K092648 | 000 |
| 30606959000873 | K092648 | 000 |