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FDA 510(k) Application Details - K222887
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K222887
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Famidoc Technology Company Limited
No. 212 Yilong Road, Hexi Industrial Zone
Jinxia, Changan Town
Dongguan 523853 CN
Other 510(k) Applications for this Company
Contact
Amos Zou
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/2022
Decision Date
04/10/2023
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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