FUNHALER, MODEL V-201E


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K072822
Device Name FUNHALER, MODEL V-201E
Applicant
INFAMED LTD.
20310 sw 48th street
southwest ranches, 
FL 
33332

Applicant Contact john greenbaum
Correspondent
INFAMED LTD.
20310 sw 48th street
southwest ranches, 
FL 
33332

Correspodent Contact john greenbaum
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 10/02/2007
Decision Date 11/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No