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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 K013583
Device Name ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
Applicant
Rossmax International , Ltd.
12f., #189, Kang Chien Rd.
Taipei,  TW 114
Applicant Contact MICHAEL YEH
Correspondent
Rossmax International , Ltd.
12f., #189, Kang Chien Rd.
Taipei,  TW 114
Correspondent Contact MICHAEL YEH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/30/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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