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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K790794
Device Name SIEMENS CARDIOSTAT 701
Original Applicant
ELMED, INC.
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/24/1979
Decision Date 05/31/1979
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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