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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph, ambulatory (without analysis)
510(k) Number K112573
Device Name EZSLEEP SLEEP QUALITY RECORDER
Applicant
PLATINUM TEAM CO., LTD
396 DAYE ROAD
TAIPAI,  TW 11268
Applicant Contact JAMES HO
Correspondent
PLATINUM TEAM CO., LTD
396 DAYE ROAD
TAIPAI,  TW 11268
Correspondent Contact JAMES HO
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received09/06/2011
Decision Date 03/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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