FDA 510(k) Application Details - K220514

Device Classification Name Pad, Heating, Powered

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510(K) Number K220514
Device Name Pad, Heating, Powered
Applicant MibeTec, GmbH
Munchener Strasse 15
Brehna D-06796 DE
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Contact Oliver Grunert
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Regulation Number 890.5740

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Classification Product Code IRT
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Date Received 02/22/2022
Decision Date 06/23/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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