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FDA 510(k) Application Details - K180432
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K180432
Device Name
Computer, Diagnostic, Programmable
Applicant
Shenzhen Carewell Electronics., Ltd
2/F, Building 1, Glory Medical Industrial Park
NO.2, Baolong Road 5, Longgang
Shenzhen 518116 CN
Other 510(k) Applications for this Company
Contact
Chang Liu
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/2018
Decision Date
11/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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