The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 8500d And 8500d-608.
| Device ID | K894244 |
| 510k Number | K894244 |
| Device Name: | DEVILBISS MODEL 8500D AND 8500D-608 |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Terry O'brien |
| Correspondent | Terry O'brien DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-21 |
| Decision Date | 1989-10-06 |