FDA 510(k) Application Details - K190347

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K190347
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Hivox Biotek Inc. 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City 24158 TW Other 510(k) Applications for this Company
Contact	Marx Lee Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2019
Decision Date	03/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review