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FDA 510(k)

TeraRecon Cardiac.Chambers.MR (1.0.0)

K-Number: K241312 · 2024-11-05

ApplicantTerarecon,Inc.
Decision Date2024-11-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TeraRecon Cardiac.Chambers.MR (1.0.0) is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2024-11-05 under approval number K241312. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TeraRecon Cardiac.Chambers.MR (1.0.0)?

TeraRecon Cardiac.Chambers.MR (1.0.0) is a medical device that received FDA 510(k) clearance on 2024-11-05. It is manufactured by Terarecon,Inc.. The 510(k) number is K241312.

When was TeraRecon Cardiac.Chambers.MR (1.0.0) approved by the FDA?

TeraRecon Cardiac.Chambers.MR (1.0.0) received FDA 510(k) clearance on 2024-11-05, under approval number K241312.

What company makes TeraRecon Cardiac.Chambers.MR (1.0.0)?

TeraRecon Cardiac.Chambers.MR (1.0.0) is manufactured by Terarecon,Inc..

What is the FDA product code for TeraRecon Cardiac.Chambers.MR (1.0.0)?

The FDA product code for TeraRecon Cardiac.Chambers.MR (1.0.0) is QIH.

Related Clinical Trials

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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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