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FDA 510(k) Application Details - K221129
Device Classification Name
More FDA Info for this Device
510(K) Number
K221129
Device Name
CloudTMS for OCD
Applicant
TeleEMG, LLC
7304 Beverly Blvd, #357
Los Angeles, CA 90036 US
Other 510(k) Applications for this Company
Contact
Joe F Jabre
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QCI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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