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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 K882955
Device Name SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
Applicant
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Applicant Contact DAVID CROMWICK
Correspondent
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Correspondent Contact DAVID CROMWICK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/14/1988
Decision Date 01/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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