Bindex BI-100

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-100.

Pre-market Notification Details

Device IDK152020
510k NumberK152020
Device Name:Bindex BI-100
ClassificationBone Sonometer
Applicant BONE INDEX FINLAND, LTD. MICROKATU 1 Kuopio,  FI 70211
ContactJanne Karjalainen
CorrespondentJanne Karjalainen
BONE INDEX FINLAND, LTD. MICROKATU 1 Kuopio,  FI 70211
Product CodeMUA  
CFR Regulation Number892.1180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-21
Decision Date2016-05-13
Summary:summary

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