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FDA 510(k)

TME Temporary Myocardial Electrode

K-Number: K232261 · 2024-04-26

ApplicantOsypka AG
Decision Date2024-04-26
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TME Temporary Myocardial Electrode is a medical device manufactured by Osypka AG. It received FDA 510(k) clearance on 2024-04-26 under approval number K232261. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TME Temporary Myocardial Electrode?

TME Temporary Myocardial Electrode is a medical device that received FDA 510(k) clearance on 2024-04-26. It is manufactured by Osypka AG. The 510(k) number is K232261.

When was TME Temporary Myocardial Electrode approved by the FDA?

TME Temporary Myocardial Electrode received FDA 510(k) clearance on 2024-04-26, under approval number K232261.

What company makes TME Temporary Myocardial Electrode?

TME Temporary Myocardial Electrode is manufactured by Osypka AG.

What is the FDA product code for TME Temporary Myocardial Electrode?

The FDA product code for TME Temporary Myocardial Electrode is LDF.

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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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