The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Airsep Impulse.
| Device ID | K962766 |
| 510k Number | K962766 |
| Device Name: | AIRSEP IMPULSE |
| Classification | Conserver, Oxygen |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Mark Mizerkiewicz |
| Correspondent | Mark Mizerkiewicz AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-10-10 |