FDA 510(k) Application Details - K202514

Device Classification Name	Bone Sonometer   More FDA Info for this Device
510(K) Number	K202514
Device Name	Bone Sonometer
Applicant	Echolight S.p.A. Via Raffaello Sanzio, 18 Lecce 73100 IT Other 510(k) Applications for this Company
Contact	Giovanna De Masi 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	08/31/2020
Decision Date	02/25/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review