QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K112824
Device Name QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
Applicant
QUALITY LIFE TECHNOLOGIES CO;LTD
3500 s.dupont highway
dover, 
DE 
19901

Applicant Contact leon lu
Correspondent
QUALITY LIFE TECHNOLOGIES CO;LTD
3500 s.dupont highway
dover, 
DE 
19901

Correspodent Contact leon lu
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 09/28/2011
Decision Date 06/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No