Bindex BI-2

Bone Sonometer

Bone Index Finland Ltd.

The following data is part of a premarket notification filed by Bone Index Finland Ltd. with the FDA for Bindex Bi-2.

Pre-market Notification Details

Device IDK211350
510k NumberK211350
Device Name:Bindex BI-2
ClassificationBone Sonometer
Applicant Bone Index Finland Ltd. Savilahdentie 14 Kuopio,  FI 70700
ContactJanne Karjalainen
CorrespondentJanne Karjalainen
Bone Index Finland Ltd. Savilahdentie 14 Kuopio,  FI 70700
Product CodeMUA  
CFR Regulation Number892.1180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2022-04-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.