Cleared Traditional

RT Carbon ECG Leads

K240087 · Ivy Biomedical Systems, Inc. · Cardiovascular
Sep 2024
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K240087 is an FDA 510(k) clearance for the RT Carbon ECG Leads, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on September 13, 2024, 246 days after receiving the submission on January 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K240087 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2024
Decision Date September 13, 2024
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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