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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 K101123
Device Name NEXFIN MODEL 2
Applicant
Bmeye B.V.
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM F GREENROSE
Correspondent
Bmeye B.V.
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM F GREENROSE
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   DSB  
Date Received04/22/2010
Decision Date 10/28/2010
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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