The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Seal Ring For Nasal Cpap.
| Device ID | K921499 |
| 510k Number | K921499 |
| Device Name: | SEAL RING FOR NASAL CPAP |
| Classification | Mask, Oxygen |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | David L Gast |
| Correspondent | David L Gast DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1992-09-17 |