WATCHHALER


Device Classification Name

holding chambers, direct patient interface

510(k) Number K080100
Device Name WATCHHALER
Applicant
ACTIVAERO AMERICA, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
ACTIVAERO AMERICA, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5630
Classification Product Code
NVP  
Date Received 01/14/2008
Decision Date 06/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No