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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K131572
Device Name MICRO AMBULATORY ECG RECORDER
Applicant
Dimetek Digital Medical Technologies, Ltd.
3/F-A2, Unit 8, Xing Hua Bldg., 6th Industrial Rd.,
Shekou, Shenzhen,  CN
Applicant Contact JIMMY GUAN
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/31/2013
Decision Date 07/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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