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FDA Product Code

FDA Product Code QVD — Clearance Directory

Device Class
Class II
Assigned Panel
Radiology
21 CFR Citation
892.2055

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN220063 Caption Interpretation Automated Ejection Fraction Software Caption Health, Inc. 2023-02-24 Direct —

Product code QVD · Class II · Radiology. Data: openFDA.