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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 K993460
Device Name ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
Applicant
Rossmax International , Ltd.
2f. # 8, Alley 20 Lane 106
Section 3, Nan Kang Rd.
Taipei,  TW
Applicant Contact MICHAEL YEH
Correspondent
Rossmax International , Ltd.
2f. # 8, Alley 20 Lane 106
Section 3, Nan Kang Rd.
Taipei,  TW
Correspondent Contact MICHAEL YEH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/13/1999
Decision Date 01/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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