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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K070411
Device Name AMSURE NEBULIZER
Applicant
Amsino International, Inc.
855 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact CHING C SEAH
Correspondent
Amsino International, Inc.
855 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact CHING C SEAH
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/12/2007
Decision Date 10/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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