FDA 510(k) Application Details - K191112

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K191112
Device Name	Densitometer, Bone
Applicant	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 3030 Ohmeda Drive Madison, WI 53718 US Other 510(k) Applications for this Company
Contact	Martha Kamrow Other 510(k) Applications for this Contact
Regulation Number	892.1170   More FDA Info for this Regulation Number
Classification Product Code	KGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2019
Decision Date	09/19/2019
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