Caption Guidance
K-Number: K201992 · 2020-09-18
ApplicantCaption Health
Decision Date2020-09-18
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Caption Guidance is a medical device manufactured by Caption Health. It received FDA 510(k) clearance on 2020-09-18 under approval number K201992. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Caption Guidance?
Caption Guidance is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Caption Health. The 510(k) number is K201992.
When was Caption Guidance approved by the FDA?
Caption Guidance received FDA 510(k) clearance on 2020-09-18, under approval number K201992.
What company makes Caption Guidance?
Caption Guidance is manufactured by Caption Health.
What is the FDA product code for Caption Guidance?
The FDA product code for Caption Guidance is QJU.
Other Devices by Caption Health
Related Devices (Code: QJU)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.