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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 K873533
Device Name SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
Applicant
Medical Electronics Laboratories, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact MARVIN ROSENBAUM
Correspondent
Medical Electronics Laboratories, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact MARVIN ROSENBAUM
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/01/1987
Decision Date 01/29/1988
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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