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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 K092859
Device Name MERITS MODEL N SERIES NEBULIZER COMPRESSORS
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG,  TW 407
Applicant Contact STEVE CHAO
Correspondent
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG,  TW 407
Correspondent Contact STEVE CHAO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/17/2009
Decision Date 07/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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