FDA 510(k) Application Details - K241536

Device Classification Name	More FDA Info for this Device
510(K) Number	K241536
Device Name	trophon Wireless Ultrasound Probe Holder
Applicant	Nanosonics Limited 7-11 Talavera Road Macquarie Park 2113 AU Other 510(k) Applications for this Company
Contact	Nancy Kaiser Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2024
Decision Date	09/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review