FDA 510(k)

RT Carbon ECG Leads

K-Number: K240087 · 2024-09-13

Decision Date2024-09-13

Product CodeDSA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RT Carbon ECG Leads is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240087. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT Carbon ECG Leads?

RT Carbon ECG Leads is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K240087.

When did RT Carbon ECG Leads receive FDA 510(k) clearance?

RT Carbon ECG Leads received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240087.

Who is the listed applicant for RT Carbon ECG Leads?

The FDA 510(k) record lists Ivy Biomedical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT Carbon ECG Leads?

The FDA product code for RT Carbon ECG Leads is DSA.

Other records listing Ivy Biomedical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.