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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K010190
Device Name WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
Applicant
ROSSMAX INTERNATIONL LTD.
12F, NO. 189, KANG CHIEN RD.
TAIPEI,  TW 114
Applicant Contact MICHAEL YEH
Correspondent
ROSSMAX INTERNATIONL LTD.
12F, NO. 189, KANG CHIEN RD.
TAIPEI,  TW 114
Correspondent Contact MICHAEL YEH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/22/2001
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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