FDA 510(k)

Bindex BI-2

K-Number: K211350 · 2022-04-29

Decision Date2022-04-29

Product CodeMUA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bindex BI-2 is the device name listed in this FDA 510(k) record. The listed applicant is Bone Index Finland , Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) 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. The listed applicant is Bone Index Finland , Ltd.. The 510(k) number is K211350.

When did Bindex BI-2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Bindex BI-2?

The FDA 510(k) record lists Bone Index Finland , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bone Index Finland , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161971Bindex BI-2 K152020Bindex BI-100

Related Devices (Code: MUA)

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.