The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss 9000 Series Cpap, Model 9001.
| Device ID | K011229 |
| 510k Number | K011229 |
| Device Name: | DEVILBISS 9000 SERIES CPAP, MODEL 9001 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Jim Froehlich |
| Correspondent | Jim Froehlich SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-07-11 |