FDA 510(k) Application Details - K161971

Device Classification Name	Bone Sonometer   More FDA Info for this Device
510(K) Number	K161971
Device Name	Bone Sonometer
Applicant	BONE INDEX FINLAND, LTD. MICROKATU 1 KUOPIO 70211 FI Other 510(k) Applications for this Company
Contact	Janne Karjalainen Other 510(k) Applications for this Contact
Regulation Number	892.1180   More FDA Info for this Regulation Number
Classification Product Code	MUA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2016
Decision Date	01/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review