FDA 510(k) Application Details - K242525

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K242525
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant Nerbio Medical Software Platforms, Inc.
1900 Camden Ave
San Jose, CA 955124 US
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Contact Lloyd Leonard
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 08/26/2024
Decision Date 12/05/2024
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 Y
Expedited Review

FDA Source Information for K242525


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