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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 K832772
Device Name SATURN-24HR. HOLTER SCANNER
Applicant
Hittman Medical Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hittman Medical Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/16/1983
Decision Date 11/03/1983
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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