The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss 5 Liter Oxygen Concentrator.
| Device ID | K991722 |
| 510k Number | K991722 |
| Device Name: | DEVILBISS 5 LITER OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Greg Clites |
| Correspondent | Greg Clites SUNRISE MEDICAL HHG, INC. 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 | 1999-05-20 |
| Decision Date | 1999-11-03 |
| Summary: | summary |