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FDA 510(k) Application Details - DEN220026
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN220026
Device Name
VasQ
Applicant
Laminate Medical Technologies Ltd.
24 Raoul Wallenberg St.
Tel Aviv 6971921 IL
Other 510(k) Applications for this Company
Contact
Orit Yarden
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QVQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/29/2022
Decision Date
09/26/2023
Decision
DENG -
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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