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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K840899
Device Name SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
Applicant
Litton Medical Electronics
777 Nicholas Blvd.
Elk Grove Village,  IL  60007
Applicant Contact ROBERT L CASARSA
Correspondent
Litton Medical Electronics
777 Nicholas Blvd.
Elk Grove Village,  IL  60007
Correspondent Contact ROBERT L CASARSA
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/28/1984
Decision Date 11/20/1984
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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