Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

IVY BIOMEDICAL SYSTEMS INC.

The following data is part of a premarket notification filed by Ivy Biomedical Systems Inc. with the FDA for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor.

Pre-market Notification Details

Device IDK151781
510k NumberK151781
Device Name:Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE Branford,  CT  06405
ContactDick Listro
CorrespondentDick Listro
IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE Branford,  CT  06405
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-01
Decision Date2016-05-27

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