Bindex BI-2— 510(k) K211350

Substantially Equivalent

Bone Index Finland , Ltd.

FDA 510(k) clearance K211350 for Bindex BI-2, Substantially Equivalent on 2022-04-29. Applicant: Bone Index Finland , Ltd..

Clearance details

Applicant: Bone Index Finland , Ltd.
Product code: Code MUA
Advisory panel: Radiology
Date received: 2021-05-03
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuopio, FI

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