FDA 510(k) Application Details - K242821

Device Classification Name	More FDA Info for this Device
510(K) Number	K242821
Device Name	EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Applicant	Ever Fortune.AI, Co., Ltd. 8F., No.360, Sec. 1, Jingmao Rd., Beitun Dist. Taichung City 406040 TW Other 510(k) Applications for this Company
Contact	Chang Joseph Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2024
Decision Date	02/20/2025
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