The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Golife Nasal Mask.
| Device ID | K110008 |
| 510k Number | K110008 |
| Device Name: | GOLIFE NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh, PA 15239 |
| Contact | Michelle Brinker |
| Correspondent | Michelle Brinker RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh, PA 15239 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-02-17 |
| Summary: | summary |