The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Model #7354.
| Device ID | K950849 |
| 510k Number | K950849 |
| Device Name: | MODEL #7354 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | DEVILBISS HEALTH CARE, INC. P.O. BOX 635 Somerset, PA 15501 -0635 |
| Contact | Mark D'angelo |
| Correspondent | Mark D'angelo DEVILBISS HEALTH CARE, INC. 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 | 1995-02-24 |
| Decision Date | 1996-02-08 |