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FDA 510(k) Application Details - K191556
Device Classification Name
More FDA Info for this Device
510(K) Number
K191556
Device Name
Red Dot
Applicant
Behold.AI Technologies Limited
91-97 Bohemia Road
St. Leonards-On-Sea TN37 6RJ GB
Other 510(k) Applications for this Company
Contact
Simon Rasalingham
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2019
Decision Date
02/28/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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