MRI ECG Patient Cable

System, Nuclear Magnetic Resonance Imaging

Ivy Biomedical Systems, Inc.

The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Mri Ecg Patient Cable.

Pre-market Notification Details

Device IDK192852
510k NumberK192852
Device Name:MRI ECG Patient Cable
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford,  CT  06405
ContactAlejandra Aceves
CorrespondentAlejandra Aceves
Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford,  CT  06405
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-03
Decision Date2020-03-28

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