The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Portable Oxygen Concentrator, 306 Series.
| Device ID | K081468 |
| 510k Number | K081468 |
| Device Name: | DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES |
| Classification | Generator, Oxygen, Portable |
| Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Joseph E Olsavsky |
| Correspondent | Joseph E Olsavsky SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-27 |
| Decision Date | 2008-08-25 |
| Summary: | summary |