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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 K020897
Device Name ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
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 Received03/19/2002
Decision Date 08/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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