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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K872249
Device Name SIRECUST MODEL 960 AND 961 PATIENT MONITORING
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 Number870.2300
Classification Product Code
DRT  
Date Received06/12/1987
Decision Date 07/21/1987
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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