The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Performax Se Total Face Mask.
| Device ID | K072588 |
| 510k Number | K072588 |
| Device Name: | PERFORMAX SE TOTAL FACE MASK |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita Yurko |
| Correspondent | Zita Yurko RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2007-12-18 |
| Summary: | summary |