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FDA 510(k) Application Details - K212191
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K212191
Device Name
Electrode, Cutaneous
Applicant
Voncare Medical Device Co., Ltd
Shiwan Science and Technology Industrial Park, Yongshi
Avenue East
Boluo County, Huizhou 516127 CN
Other 510(k) Applications for this Company
Contact
Jimmy Zhai
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
07/12/2021
Decision Date
10/06/2021
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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