The following data is part of a premarket notification filed by Respironics Inc. (dba Philips Respironics) with the FDA for Revolution Fullface Mask.
| Device ID | K140580 |
| 510k Number | K140580 |
| Device Name: | REVOLUTION FULLFACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS INC. (DBA PHILIPS RESPIRONICS) 1001 Murry Ridge Ln Murrysville, PA 15668 |
| Contact | Colleen Witt |
| Correspondent | Colleen Witt RESPIRONICS INC. (DBA PHILIPS RESPIRONICS) 1001 Murry Ridge Ln Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2015-01-16 |
| Summary: | summary |