FDA 510(k)

Bindex BI-100

K-Number: K152020 · 2016-05-13

Decision Date2016-05-13

Product CodeMUA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bindex BI-100 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 2016-05-13 under 510(k) number K152020. 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-100?

Bindex BI-100 is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Bone Index Finland , Ltd.. The 510(k) number is K152020.

When did Bindex BI-100 receive FDA 510(k) clearance?

Bindex BI-100 received FDA 510(k) clearance on 2016-05-13, under 510(k) number K152020.

Who is the listed applicant for Bindex BI-100?

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-100?

The FDA product code for Bindex BI-100 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.

K211350Bindex BI-2 K161971Bindex BI-2

Related Devices (Code: MUA)

K211350Bindex BI-2Bone Index Finland , Ltd.K202514EchoS FamilyEcholight S.P.A K180516EchoSEcholight S.P.A K161919UltraScan 650Cyberlogic, Inc.K161971Bindex BI-2Bone 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.