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FDA 510(k) Application Details - K202928
Device Classification Name
More FDA Info for this Device
510(K) Number
K202928
Device Name
DV. Target
Applicant
Deepvoxel INC
22 Talisman
Irvine, CA 92620 US
Other 510(k) Applications for this Company
Contact
Jerry Liu
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QKB
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More FDA Info for this Product Code
Date Received
09/29/2020
Decision Date
04/02/2021
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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