FDA 510(k) Application Details - K240347

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K240347
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant Zimmer MedizinSysteme GmbH
Junkerstrasse 9
Neu-Ulm 89231 DE
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Contact Ute Killet
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 02/05/2024
Decision Date 07/21/2024
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 K240347


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