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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 K052727
Device Name ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
Applicant
Rossmax International , Ltd.
12f., #189, Kang Chien Rd.
Taipei,  TW 114
Applicant Contact YOLANDA LIN
Correspondent
Center For Measurement Standards of Industrial
Bldg. 16, 321 Kuang Fu Rd.,Sec2
Hsinchu,,  TW
Correspondent Contact TZU-WEI LI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/29/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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