FDA 510(k) Application Details - K234153

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K234153
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	EdgeLife Technologies LLC 485 Brickell Avenue Suite 4802 Miami, FL 33031 US Other 510(k) Applications for this Company
Contact	Quinn Place Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2023
Decision Date	09/18/2024
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