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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 K900385
Device Name ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
Applicant
Parexel Intl. Corp.
One Alewife Pl.
Cambridge,  MS  02140
Applicant Contact SAYIGH, PHD
Correspondent
Parexel Intl. Corp.
One Alewife Pl.
Cambridge,  MS  02140
Correspondent Contact SAYIGH, PHD
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/29/1990
Decision Date 07/09/1991
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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