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FDA 510(k) Application Details - K221694
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K221694
Device Name
Shunt, Central Nervous System And Components
Applicant
JMED(Shenzhen) Technology Limited
7#401, Zhongxing Road, Xiuxin Community,
Kengzi Street, Pingshan District
Shenzhen City 518122 CN
Other 510(k) Applications for this Company
Contact
Anna Xiao
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/10/2022
Decision Date
02/09/2023
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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