Caption Guidance— 510(k) K201992
Substantially EquivalentCaption Health
FDA 510(k) clearance K201992 for Caption Guidance, Substantially Equivalent on 2020-09-18. Applicant: Caption Health. Device class: 2.
Clearance details
- Applicant
- Caption Health
- Product code
- Code QJU
- Device class
- Class 2
- Regulation
- 21 CFR 892.2100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brisbane, CA, US
Recent devices under product code QJU
view allMore clearances from Caption Health
view allData sourced from openFDA. This site is unofficial and independent of the FDA.