The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series.
| Device ID | K071397 |
| 510k Number | K071397 |
| Device Name: | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00088530400033 | K071397 | 000 |
| 10612479273556 | K071397 | 000 |
| 00885304022480 | K071397 | 000 |
| 00853040224734 | K071397 | 000 |
| 00885304022473 | K071397 | 000 |
| 00885304000334 | K071397 | 000 |
| 00885304002550 | K071397 | 000 |
| 00885304006770 | K071397 | 000 |
| 00885304007104 | K071397 | 000 |
| 00885304007166 | K071397 | 000 |
| 00885304020585 | K071397 | 000 |
| 10612479248158 | K071397 | 000 |
| 00885304000846 | K071397 | 000 |
| 00885304000976 | K071397 | 000 |
| 00885304002480 | K071397 | 000 |
| 00885304009689 | K071397 | 000 |
| 00885304022466 | K071397 | 000 |
| 00085304022473 | K071397 | 000 |
| 10612479273549 | K071397 | 000 |