The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Respironics Performax Total Face Mask.
| Device ID | K091271 |
| 510k Number | K091271 |
| Device Name: | RESPIRONICS PERFORMAX TOTAL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Andrew P Zeltwanger |
| Correspondent | Andrew P Zeltwanger 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-30 |
| Decision Date | 2009-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959013704 | K091271 | 000 |
| 00606959011953 | K091271 | 000 |
| 00606959008021 | K091271 | 000 |
| 00606959007994 | K091271 | 000 |
| 00606959000766 | K091271 | 000 |
| 00606959026339 | K091271 | 000 |
| 00606959023048 | K091271 | 000 |
| 00606959023031 | K091271 | 000 |
| 00606959023024 | K091271 | 000 |
| 00606959023017 | K091271 | 000 |
| 00606959023000 | K091271 | 000 |
| 00606959022997 | K091271 | 000 |
| 00606959007017 | K091271 | 000 |
| 00606959007000 | K091271 | 000 |
| 00606959006997 | K091271 | 000 |
| 00606959006980 | K091271 | 000 |
| 00606959004122 | K091271 | 000 |
| 00606959004115 | K091271 | 000 |
| 30606959000859 | K091271 | 000 |
| 30606959000866 | K091271 | 000 |
| 00606959003866 | K091271 | 000 |
| 00606959013698 | K091271 | 000 |
| 30606959013019 | K091271 | 000 |
| 30606959012982 | K091271 | 000 |
| 30606959012975 | K091271 | 000 |
| 30606959011985 | K091271 | 000 |
| 00606959011960 | K091271 | 000 |
| 00606959011946 | K091271 | 000 |
| 00606959011892 | K091271 | 000 |
| 00606959011885 | K091271 | 000 |
| 30606959011855 | K091271 | 000 |
| 30606959011848 | K091271 | 000 |
| 00606959011786 | K091271 | 000 |
| 00606959007697 | K091271 | 000 |
| 00606959004160 | K091271 | 000 |
| 00606959004153 | K091271 | 000 |
| 30606959004086 | K091271 | 000 |
| 30606959004079 | K091271 | 000 |
| 00606959001800 | K091271 | 000 |