FDA 510(k) Application Details - K202928

Device Classification Name

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510(K) Number K202928
Device Name DV. Target
Applicant Deepvoxel INC
22 Talisman
Irvine, CA 92620 US
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Contact Jerry Liu
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Regulation Number

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Classification Product Code QKB
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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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