AIRSONNETT AIRSHOWER AIR 3


Device Classification Name

cleaner, air, medical recirculating

510(k) Number K081062
Device Name AIRSONNETT AIRSHOWER AIR 3
Applicant
AIRSONETT, INC.
6470 riverview terrace
findley, 
MN 
55432

Applicant Contact constance g bundy
Correspondent
AIRSONETT, INC.
6470 riverview terrace
findley, 
MN 
55432

Correspodent Contact constance g bundy
Regulation Number 880.5045
Classification Product Code
FRF  
Date Received 04/14/2008
Decision Date 11/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No