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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 K904606
Device Name MODEL 405
Original Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 business park dr.
branford,  CT  06405
Original Contact m simon
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/10/1990
Decision Date 03/01/1991
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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