The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Performax Pediatric Se Total Face Mask.
| Device ID | K120639 |
| 510k Number | K120639 |
| Device Name: | PERFORMAX PEDIATRIC SE TOTAL FACE MASK |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh, PA 15239 |
| Contact | Michelle Brinker |
| Correspondent | Michelle Brinker RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh, PA 15239 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-02 |
| Decision Date | 2012-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30606959014542 | K120639 | 000 |
| 30606959014528 | K120639 | 000 |
| 30606959013606 | K120639 | 000 |
| 30606959013583 | K120639 | 000 |
| 00606959008069 | K120639 | 000 |
| 00606959008052 | K120639 | 000 |
| 30606959007766 | K120639 | 000 |