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FDA 510(k) Application Details - K211747
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K211747
Device Name
Blood Pressure Cuff
Applicant
Shenzhen Coreray Technology Co., Ltd.
Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park
Yousong Community, Longhua District
Shenzhen 518109 CN
Other 510(k) Applications for this Company
Contact
Simon Fan
Other 510(k) Applications for this Contact
Regulation Number
870.1120
More FDA Info for this Regulation Number
Classification Product Code
DXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/07/2021
Decision Date
09/23/2021
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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