Caption Interpretation Automated Ejection Fraction Software— 510(k) DEN220063

Name: FDA 510(k) clearance DEN220063
Creator: U.S. Food and Drug Administration
Published: 2023-02-24

Unknown

Caption Health, Inc.

FDA 510(k) clearance DEN220063 for Caption Interpretation Automated Ejection Fraction Software, Unknown on 2023-02-24. Applicant: Caption Health, Inc.. Device class: 2.

Clearance details

Applicant: Caption Health, Inc.
Product code: Code QVD
Device class: Class 2
Regulation: 21 CFR 892.2055
Advisory panel: Radiology
Date received: 2022-09-28
Decision date: 2023-02-24
Decision: Unknown
Clearance type: Direct
Location: Brisbane, CA, US

View on FDA.gov ↗

More clearances from Caption Health, Inc.

view all

K243065 — Cardiac Guidance2025-01-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.