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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 K051903
Device Name FETALGARD LITE-NIBP, MODEL FGL-NIBP
Applicant
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact JANET KWIATKOWSKI
Correspondent
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact JANET KWIATKOWSKI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/13/2005
Decision Date 12/27/2005
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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