The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Reliant Oxygen Concentrator.
| Device ID | K884581 |
| 510k Number | K884581 |
| Device Name: | RELIANT OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | AIRSEP CORP. 84 AERO DR. Buffalo, NY 14225 |
| Contact | Peter Weisenborn |
| Correspondent | Peter Weisenborn AIRSEP CORP. 84 AERO DR. Buffalo, NY 14225 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-02 |
| Decision Date | 1989-01-11 |