The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Impulse Select.
| Device ID | K001579 |
| 510k Number | K001579 |
| Device Name: | IMPULSE SELECT |
| Classification | Conserver, Oxygen |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | James A Alessi |
| Correspondent | James A Alessi 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 | 2000-05-22 |
| Decision Date | 2000-08-31 |