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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 K010498
Device Name WRISTWATCH BLOOD PRESSURE MONITOR A46
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 Received02/21/2001
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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