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FDA 510(k)

Bindex BI-2

K-Number: K211350 · 2022-04-29

ApplicantBone Index Finland , Ltd.
Decision Date2022-04-29
Product CodeMUA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bindex BI-2 is a medical device manufactured by Bone Index Finland , Ltd.. It received FDA 510(k) clearance on 2022-04-29 under approval number K211350. The device is classified under product code MUA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bindex BI-2?

Bindex BI-2 is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Bone Index Finland , Ltd.. The 510(k) number is K211350.

When was Bindex BI-2 approved by the FDA?

Bindex BI-2 received FDA 510(k) clearance on 2022-04-29, under approval number K211350.

What company makes Bindex BI-2?

Bindex BI-2 is manufactured by Bone Index Finland , Ltd..

What is the FDA product code for Bindex BI-2?

The FDA product code for Bindex BI-2 is MUA.

Other Devices by Bone Index Finland , Ltd.

K152020Bindex BI-100 K161971Bindex BI-2

Related Devices (Code: MUA)

K152020Bindex BI-100Bone Index Finland , Ltd. K161919UltraScan 650Cyberlogic, Inc. K161971Bindex BI-2Bone Index Finland , Ltd. K180516EchoSEcholight S.P.A K202514EchoS FamilyEcholight S.P.A

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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