The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Nasal Cpap Mask, 9354 Series.
| Device ID | K042455 |
| 510k Number | K042455 |
| Device Name: | DEVILBISS NASAL CPAP MASK, 9354 SERIES |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Allan Jones |
| Correspondent | Allan Jones SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2005-01-14 |
| Summary: | summary |