KOO SMALL VOLUME NEBULIZER (SVN)


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K112041
Device Name KOO SMALL VOLUME NEBULIZER (SVN)
Applicant
KOO(SHANGHAI)INDUSTRIES CO., LTD.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
KOO(SHANGHAI)INDUSTRIES CO., LTD.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 07/18/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No