The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Af541 Ee Full Face Mask.
| Device ID | K150639 |
| 510k Number | K150639 |
| Device Name: | AF541 EE Full Face Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| 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 |