The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Total Face Mask.
| Device ID | K992969 |
| 510k Number | K992969 |
| Device Name: | RESPIRONICS TOTAL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RESPIRONICS, INC. 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 | 1999-09-03 |
| Decision Date | 1999-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30606959020253 | K992969 | 000 |
| 00606959002586 | K992969 | 000 |