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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 K992425
Device Name TES-20
Applicant
Tes Electrical Electronic Corp.
#57 Jen-Ai Rd. Sec. 2
Taipei, Taiwan 300,  CN 300
Applicant Contact MIKE Z CHEN
Correspondent
Tes Electrical Electronic Corp.
#57 Jen-Ai Rd. Sec. 2
Taipei, Taiwan 300,  CN 300
Correspondent Contact MIKE Z CHEN
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received07/21/1999
Decision Date 10/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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