The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Revolution Full Face Mask.
| Device ID | K142554 |
| 510k Number | K142554 |
| Device Name: | Revolution Full Face Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Amy Macevoy |
| Correspondent | Amy Macevoy Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-11 |
| Decision Date | 2015-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959062535 | K142554 | 000 |
| 00606959062528 | K142554 | 000 |