The following data is part of a premarket notification filed by Airsonett, Inc. with the FDA for Airsonnett Airshower Air 3.
| Device ID | K081062 |
| 510k Number | K081062 |
| Device Name: | AIRSONNETT AIRSHOWER AIR 3 |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | AIRSONETT, INC. 6470 RIVERVIEW TERRACE Findley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy AIRSONETT, INC. 6470 RIVERVIEW TERRACE Findley, MN 55432 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2008-11-07 |
| Summary: | summary |