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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 K963576
Device Name MOBILE MEDICAL MONITOR (M3(A))
Applicant
Scientific Applications
4224 Campus Point Court
San Diego,  CA  92121 -2211
Applicant Contact ALAN SORGI
Correspondent
Scientific Applications
4224 Campus Point Court
San Diego,  CA  92121 -2211
Correspondent Contact ALAN SORGI
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/06/1996
Decision Date 02/28/1997
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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