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FDA 510(k) Application Details - K240165
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K240165
Device Name
Blood Pressure Cuff
Applicant
Wenzhou Longwan Medical Device Factory
Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou
Industrial Cluster District
Wenzhou 325026 CN
Other 510(k) Applications for this Company
Contact
Bernard Zeng
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
01/22/2024
Decision Date
03/20/2024
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
FDA Source Information for K240165
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