The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 5500.
| Device ID | K946095 |
| 510k Number | K946095 |
| Device Name: | DEVILBISS MODEL 5500 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Barry Iddon |
| Correspondent | Barry Iddon DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-14 |
| Decision Date | 1995-08-24 |