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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., #189, Kang Chien Rd.
Taipei,  TW 114
Applicant Contact MICHAEL YEH
Correspondent
Rossmax Internationl , Ltd.
12f., #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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