FibroScan 530 Compact
K-Number: K160524 · 2016-03-18
ApplicantEchosens
Decision Date2016-03-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FibroScan 530 Compact is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2016-03-18 under approval number K160524. 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 530 Compact?
FibroScan 530 Compact is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Echosens. The 510(k) number is K160524.
When was FibroScan 530 Compact approved by the FDA?
FibroScan 530 Compact received FDA 510(k) clearance on 2016-03-18, under approval number K160524.
What company makes FibroScan 530 Compact?
FibroScan 530 Compact is manufactured by Echosens.
What is the FDA product code for FibroScan 530 Compact?
The FDA product code for FibroScan 530 Compact is IYO.
Related Clinical Trials
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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.