Decision Date2024-04-26
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TME Temporary Myocardial Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Osypka AG. It received FDA 510(k) clearance on 2024-04-26 under 510(k) 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. The listed applicant is Osypka AG. The 510(k) number is K232261.
When did TME Temporary Myocardial Electrode receive FDA 510(k) clearance?
TME Temporary Myocardial Electrode received FDA 510(k) clearance on 2024-04-26, under 510(k) number K232261.
Who is the listed applicant for TME Temporary Myocardial Electrode?
The FDA 510(k) record lists Osypka AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TME Temporary Myocardial Electrode?
The FDA product code for TME Temporary Myocardial Electrode is LDF.
Related Devices (Code: 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.