K-number	K232261
Device name	TME Temporary Myocardial Electrode
Applicant	Osypka AG
Product code	LDF
Device class	Class II
Decision date	Apr 26, 2024
Decision	Substantially Equivalent
Regulation	870.3680

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Source

View the full FDA submission: accessdata.fda.gov

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TME Temporary Myocardial Electrode

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