FDA 510(k) Application Details - K212434

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K212434
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant MIPM Mammendorfer Institut fⁿr Physik und Medizin GmbH
Oskar-von-Miller Str. 6
Mammendorf 82291 DE
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Contact Jennifer Rosenheimer
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 08/04/2021
Decision Date 05/05/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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