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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 K060342
Device Name ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
Applicant
ROSSMAX INTERNATIONAL LTD.
12F., NO.189, KANG CHIEN RD.
TAIPEI,  TW 114
Applicant Contact MARK LIN
Correspondent
ROSSMAX INTERNATIONAL LTD.
12F., NO.189, KANG CHIEN RD.
TAIPEI,  TW 114
Correspondent Contact MARK LIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/10/2006
Decision Date 04/04/2006
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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