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FDA 510(k) Application Details - K131923
Device Classification Name
Stimulator, Neuromuscular, External Functional
More FDA Info for this Device
510(K) Number
K131923
Device Name
Stimulator, Neuromuscular, External Functional
Applicant
TECHLINK INTERNATIONAL
PO BOX 694125
MIAMI, FL 33269 US
Other 510(k) Applications for this Company
Contact
TARA CONRAD
Other 510(k) Applications for this Contact
Regulation Number
882.5810
More FDA Info for this Regulation Number
Classification Product Code
GZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2013
Decision Date
07/03/2014
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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