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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K091716
Device Name MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
Applicant
Merits Health Products Co., Ltd.
9, Rd. 36
Taichung Industrial Park
Taichung,  TW 407
Applicant Contact STEVE CHAO
Correspondent
Merits Health Products Co., Ltd.
9, Rd. 36
Taichung Industrial Park
Taichung,  TW 407
Correspondent Contact STEVE CHAO
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/10/2009
Decision Date 04/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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