Cleared Traditional

MRI ECG Patient Cable

K192852 · Ivy Biomedical Systems, Inc. · Cardiovascular
Mar 2020
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K192852 is an FDA 510(k) clearance for the MRI ECG Patient Cable, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 28, 2020, 177 days after receiving the submission on October 3, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K192852 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2019
Decision Date March 28, 2020
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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