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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K133980
Device Name PANTHEON ELECTROSTIMULATOR
Applicant
PANTHEON RESEARCH
1468 HARWELL AVE
CROFTON,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
PANTHEON RESEARCH
1468 HARWELL AVE
CROFTON,  MD  21114
Correspondent Contact YOLANDA SMITH
Classification Product Code
BWK  
Date Received12/27/2013
Decision Date 11/07/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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