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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 K964153
Device Name ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
Applicant
Rossmax International , Ltd.
2f. # 10, Alley 20 Lane 106
Sec 3 Non Kang Rd.
Taipei,  TW
Applicant Contact MICHAEL YEH
Correspondent
Rossmax International , Ltd.
2f. # 10, Alley 20 Lane 106
Sec 3 Non Kang Rd.
Taipei,  TW
Correspondent Contact MICHAEL YEH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/16/1996
Decision Date 06/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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