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FDA 510(k) Application Details - K182136
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K182136
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
Shenzhen OSTO Technology Co., Ltd.
No.43 Longfeng Road, Xinsheng Community
Shenzhen CN
Other 510(k) Applications for this Company
Contact
Li Yang
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
08/06/2018
Decision Date
10/10/2019
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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