The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss Pd1000.
| Device ID | K020329 |
| 510k Number | K020329 |
| Device Name: | DEVILBISS PD1000 |
| Classification | Conserver, Oxygen |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Brian Hershey |
| Correspondent | Brian Hershey SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-31 |
| Decision Date | 2002-06-19 |
| Summary: | summary |