The following data is part of a premarket notification filed by Everest & Jennings, Inc. with the FDA for Premier O2 Oxygen Concentrator.
| Device ID | K844223 |
| 510k Number | K844223 |
| Device Name: | PREMIER O2 OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
| Contact | Ken Molinelli |
| Correspondent | Ken Molinelli EVEREST & JENNINGS, INC. 3233 E MISSION OAKS BLVD. Camarillo, CA 93010 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1984-12-24 |