Caption Interpretation Automated Ejection Fraction Software— 510(k) K200621
Substantially EquivalentCaption Health
FDA 510(k) clearance K200621 for Caption Interpretation Automated Ejection Fraction Software, Substantially Equivalent on 2020-07-22. Applicant: Caption Health.
Clearance details
- Applicant
- Caption Health
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brisbane, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.