FibroScan® 630
K-Number: K200655 · 2020-07-16
ApplicantEchosens
Decision Date2020-07-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FibroScan® 630 is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2020-07-16 under approval number K200655. 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® 630?
FibroScan® 630 is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Echosens. The 510(k) number is K200655.
When was FibroScan® 630 approved by the FDA?
FibroScan® 630 received FDA 510(k) clearance on 2020-07-16, under approval number K200655.
What company makes FibroScan® 630?
FibroScan® 630 is manufactured by Echosens.
What is the FDA product code for FibroScan® 630?
The FDA product code for FibroScan® 630 is IYO.
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K212035FibroScan 230
K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
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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.