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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 K051546
Device Name BPCALIBRATOR MC3000/MC3100
Applicant
Healthstats International Pte. , Ltd.
565 W35739 Piper Rd.
Eagle,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/13/2005
Decision Date 06/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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