FDA 510(k) Application Details - K233926

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K233926
Device Name Stimulator, Muscle, Powered
Applicant Mettler Electronics Corporation
1333 South Claudina St
Anaheim, CA 92805 US
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Contact An Le
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 12/13/2023
Decision Date 03/21/2024
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

FDA Source Information for K233926


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