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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, cardiac (incl. cardiotachometer & rate alarm)
510(k) Number K151781
Device Name Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
Applicant
IVY BIOMEDICAL SYSTEMS INC.
11 BUSINESS PARK DRIVE
BRANFORD,  CT  06405
Applicant Contact DICK LISTRO
Correspondent
IVY BIOMEDICAL SYSTEMS INC.
11 BUSINESS PARK DRIVE
BRANFORD,  CT  06405
Correspondent Contact DICK LISTRO
Regulation Number870.2300
Classification Product Code
DRT  
Date Received07/01/2015
Decision Date 05/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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