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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 K012801
Device Name N2000 BASE STATION, N2001 NURSE STATION
Applicant
Neptec Design Group, Ltd.
103 Nolen Ln.
Chapel Hill,  NC  27516
Applicant Contact CHARLES H KYPER
Correspondent
Neptec Design Group, Ltd.
103 Nolen Ln.
Chapel Hill,  NC  27516
Correspondent Contact CHARLES H KYPER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/21/2001
Decision Date 11/14/2001
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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