FDA 510(k) Application Details - K230209

Device Classification Name	More FDA Info for this Device
510(K) Number	K230209
Device Name	Sonix Health
Applicant	Ontact Health Co., Ltd. 5f, 50-5, Ewhayeodae-gil, Seodaemun-gu Seoul KS013/03764 KR Other 510(k) Applications for this Company
Contact	Hyuk-Jae Chang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2023
Decision Date	10/20/2023
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