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FDA 510(k) Application Details - K222252
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K222252
Device Name
Electrode, Cutaneous
Applicant
Shenzhen Roundwhale Technology Co., Ltd.
202,2/F, Building 27, Dafa Industrial Park, Longxi Community
Longgang Street, Longgang District
Shenzhen 518108 CN
Other 510(k) Applications for this Company
Contact
Zeng Chunming
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/27/2022
Decision Date
01/19/2023
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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