FibroScan 230
K-Number: K212035 · 2021-07-30
ApplicantEchosens
Decision Date2021-07-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FibroScan 230 is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2021-07-30 under approval number K212035. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FibroScan 230?
FibroScan 230 is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Echosens. The 510(k) number is K212035.
When was FibroScan 230 approved by the FDA?
FibroScan 230 received FDA 510(k) clearance on 2021-07-30, under approval number K212035.
What company makes FibroScan 230?
FibroScan 230 is manufactured by Echosens.
What is the FDA product code for FibroScan 230?
The FDA product code for FibroScan 230 is IYO.
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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.