FDA 510(k) Application Details - K242496

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K242496
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Eieling Technology (Shenzhen) Limited Rm 610, Bldg E, Qihang Innovation Development Park No. 1008 Songhai Rd., Yangguang Community, Xili St. Nanshan District Shenzhen 518052 CN Other 510(k) Applications for this Company
Contact	Salon Chen Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2024
Decision Date	11/19/2024
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