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FDA 510(k) Application Details - K232675
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K232675
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
Leslie Peng
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
09/01/2023
Decision Date
10/05/2023
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
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