The following data is part of a premarket notification filed by Medical Depot with the FDA for Drive Solstice Oxygen Concentrator.
| Device ID | K080391 |
| 510k Number | K080391 |
| Device Name: | DRIVE SOLSTICE OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | MEDICAL DEPOT 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-03-18 |
| Summary: | summary |