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FDA 510(k)

FibroScan 430 Mini+

K-Number: K172142 · 2017-09-13

ApplicantEchosens
Decision Date2017-09-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FibroScan 430 Mini+ is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2017-09-13 under approval number K172142. 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 430 Mini+?

FibroScan 430 Mini+ is a medical device that received FDA 510(k) clearance on 2017-09-13. It is manufactured by Echosens. The 510(k) number is K172142.

When was FibroScan 430 Mini+ approved by the FDA?

FibroScan 430 Mini+ received FDA 510(k) clearance on 2017-09-13, under approval number K172142.

What company makes FibroScan 430 Mini+?

FibroScan 430 Mini+ is manufactured by Echosens.

What is the FDA product code for FibroScan 430 Mini+?

The FDA product code for FibroScan 430 Mini+ is IYO.

Related Clinical Trials

NCT06877026 FibroScan-Reproducibility and Repeatability Study COMPLETED

Other Devices by Echosens

K160524FibroScan 530 Compact K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) K200655FibroScan® 630 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.

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