The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss Nebulizer Model 800.
| Device ID | K993492 |
| 510k Number | K993492 |
| Device Name: | DEVILBISS NEBULIZER MODEL 800 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Frank Clementi |
| Correspondent | Frank Clementi SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-15 |
| Decision Date | 2000-04-21 |
| Summary: | summary |