The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Autoadjust, Model 9054 Series.
| Device ID | K043282 |
| 510k Number | K043282 |
| Device Name: | DEVILBISS AUTOADJUST, MODEL 9054 SERIES |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Stephen Krepelka |
| Correspondent | Stephen Krepelka SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2005-02-11 |
| Summary: | summary |