The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 4650 Compressor Neubulizer.
| Device ID | K931015 |
| 510k Number | K931015 |
| Device Name: | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER |
| Classification | Compressor, Air, Portable |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Richard J Kocinski |
| Correspondent | Richard J Kocinski DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-26 |
| Decision Date | 1993-09-30 |