The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 7351d Revitalizer Cpap System.
| Device ID | K893388 |
| 510k Number | K893388 |
| Device Name: | DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| 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 | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-01 |
| Decision Date | 1989-06-23 |