FDA 510(k) Application Details - K213760

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K213760
Device Name	Densitometer, Bone
Applicant	HeartLung Corporation 1124 W Carson St Torrance, CA 90502 US Other 510(k) Applications for this Company
Contact	Morteza Naghavi 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	12/01/2021
Decision Date	07/29/2022
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