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FDA 510(k)

RT Carbon ECG Leads

K-Number: K240087 · 2024-09-13

ApplicantIvy Biomedical Systems, Inc.
Decision Date2024-09-13
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RT Carbon ECG Leads is a medical device manufactured by Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2024-09-13 under approval 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. It is manufactured by Ivy Biomedical Systems, Inc.. The 510(k) number is K240087.

When was RT Carbon ECG Leads approved by the FDA?

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

What company makes RT Carbon ECG Leads?

RT Carbon ECG Leads is manufactured by Ivy Biomedical Systems, Inc..

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

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

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Related Devices (Code: DSA)

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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.

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