The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 7427d.
| Device ID | K913316 |
| 510k Number | K913316 |
| Device Name: | DEVILBISS MODEL 7427D |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Terrence M O'brien |
| Correspondent | Terrence M O'brien 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-24 |
| Decision Date | 1991-12-11 |