The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Airsep Newlife Dual Six Oxygen Concentrator (modification).
| Device ID | K960309 |
| 510k Number | K960309 |
| Device Name: | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) |
| Classification | Generator, Oxygen, Portable |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Edward E Vrana |
| Correspondent | Edward E Vrana AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-05 |
| Decision Date | 1997-02-28 |