The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Mystique Ultrasonic Nebulizer.
| Device ID | K983002 |
| 510k Number | K983002 |
| Device Name: | MYSTIQUE ULTRASONIC NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Edward Vrana |
| Correspondent | Edward Vrana AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-10-16 |