The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Performax Pediatric Ee Total Face Mask.
| Device ID | K120562 |
| 510k Number | K120562 |
| Device Name: | PERFORMAX PEDIATRIC EE TOTAL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-24 |
| Decision Date | 2012-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30606959014535 | K120562 | 000 |
| 30606959014511 | K120562 | 000 |
| 30606959013590 | K120562 | 000 |
| 30606959013576 | K120562 | 000 |
| 30606959012470 | K120562 | 000 |
| 00606959008045 | K120562 | 000 |
| 00606959008038 | K120562 | 000 |
| 30606959007742 | K120562 | 000 |
| 30606959007735 | K120562 | 000 |