Caption Interpretation Automated Ejection Fraction Software— 510(k) K210747

Name: FDA 510(k) clearance K210747
Creator: U.S. Food and Drug Administration
Published: 2022-01-19

Substantially Equivalent

Caption Health

FDA 510(k) clearance K210747 for Caption Interpretation Automated Ejection Fraction Software, Substantially Equivalent on 2022-01-19. Applicant: Caption Health. Device class: 2.

Clearance details

Applicant: Caption Health
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-03-12
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Caption Health

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K201992 — Caption Guidance2020-09-18
K200621 — Caption Interpretation Automated Ejection Fraction Software2020-07-22
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Data sourced from openFDA. This site is unofficial and independent of the FDA.