The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Sleeper Mask System.
| Device ID | K904344 |
| 510k Number | K904344 |
| Device Name: | SLEEPER MASK SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | David Gast |
| Correspondent | David Gast DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1991-05-01 |