The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Af541 Se Full Face Mask.
| Device ID | K150638 |
| 510k Number | K150638 |
| Device Name: | AF541 SE Full Face Mask |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Shaylee Masilunas |
| Correspondent | Shaylee Masilunas Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-09-18 |
| Summary: | summary |