FDA 510(k) Application Details - K230511

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K230511
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	MAUI Imaging 3600 136th Pl SE, Ste 300 Bellevue, WA 98006 US Other 510(k) Applications for this Company
Contact	David Specht 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	02/24/2023
Decision Date	10/25/2023
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