Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bindex BI-100

K-Number: K152020 · 2016-05-13

ApplicantBone Index Finland , Ltd.
Decision Date2016-05-13
Product CodeMUA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bindex BI-100 is a medical device manufactured by Bone Index Finland , Ltd.. It received FDA 510(k) clearance on 2016-05-13 under approval 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. It is manufactured by Bone Index Finland , Ltd.. The 510(k) number is K152020.

When was Bindex BI-100 approved by the FDA?

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

What company makes Bindex BI-100?

Bindex BI-100 is manufactured by Bone Index Finland , Ltd..

What is the FDA product code for Bindex BI-100?

The FDA product code for Bindex BI-100 is MUA.

Other Devices by Bone Index Finland , Ltd.

K161971Bindex BI-2 K211350Bindex BI-2

Related Devices (Code: MUA)

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

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.

↑