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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, electrocardiograph
510(k) Number K833695
Device Name ADULT MONITORING ELECTOR@@RODE 9431-300
Applicant
MARQUETTE ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MARQUETTE ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/18/1983
Decision Date 01/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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