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FDA 510(k) Application Details - K222867
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
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510(K) Number
K222867
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
Tianjin 300190 CN
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Contact
Liu Yi
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
NUH
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More FDA Info for this Product Code
Date Received
09/22/2022
Decision Date
12/21/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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