The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Oxygen Cylinder Filling System, 535 Series.
| Device ID | K053240 |
| 510k Number | K053240 |
| Device Name: | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES |
| Classification | Generator, Oxygen, Portable |
| Applicant | SUNRISE MEDICAL 100 DEVILBISS DRIVE Somerset, PA 15501 |
| Contact | Joseph E Olsavsky |
| Correspondent | Joseph E Olsavsky SUNRISE MEDICAL 100 DEVILBISS DRIVE 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 | 2005-11-18 |
| Decision Date | 2006-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085304002635 | K053240 | 000 |
| 00885304002642 | K053240 | 000 |
| 00885304002611 | K053240 | 000 |
| 00885304002604 | K053240 | 000 |
| 00885304002581 | K053240 | 000 |
| 00885304002574 | K053240 | 000 |
| 00885304002567 | K053240 | 000 |
| 00885304000860 | K053240 | 000 |
| 00885304000853 | K053240 | 000 |
| 00885304008859 | K053240 | 000 |
| 00885304006725 | K053240 | 000 |
| 00885304006718 | K053240 | 000 |
| 00885304006701 | K053240 | 000 |
| 00885304002635 | K053240 | 000 |
| 00885304002598 | K053240 | 000 |
| 00885304002659 | K053240 | 000 |
| 00885304002666 | K053240 | 000 |
| 00885304020936 | K053240 | 000 |
| 00885304020929 | K053240 | 000 |
| 00885304020912 | K053240 | 000 |
| 00885304011125 | K053240 | 000 |
| 00885304011026 | K053240 | 000 |
| 00885304010074 | K053240 | 000 |
| 00885304008163 | K053240 | 000 |
| 00885304003076 | K053240 | 000 |
| 00885304003069 | K053240 | 000 |
| 00885304003052 | K053240 | 000 |
| 00885304003045 | K053240 | 000 |
| 00885304003038 | K053240 | 000 |
| 00885304003021 | K053240 | 000 |
| 00885304002680 | K053240 | 000 |
| 00853040026352 | K053240 | 000 |