The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Centrox, Reliant, Ultrox, As-d+, As-e, As-g, As-j, As-k And As-l.
| Device ID | K101154 |
| 510k Number | K101154 |
| Device Name: | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L |
| Classification | Generator, Oxygen, Portable |
| Applicant | AIRSEP CORP. 401 CREEKSIDE DR. Buffalo, NY 14228 -2085 |
| Contact | Peter Weisenborn |
| Correspondent | Peter Weisenborn AIRSEP CORP. 401 CREEKSIDE DR. Buffalo, NY 14228 -2085 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-23 |
| Decision Date | 2011-03-28 |
| Summary: | summary |