FDA 510(k) Application Details - K221129

Device Classification Name

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510(K) Number K221129
Device Name CloudTMS for OCD
Applicant TeleEMG, LLC
7304 Beverly Blvd, #357
Los Angeles, CA 90036 US
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Contact Joe F Jabre
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Regulation Number

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Classification Product Code QCI
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Date Received 04/18/2022
Decision Date 03/10/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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