FDA.reportPublic FDA data

510(k) K103059

Device
TROPHON
Applicant
NANOSONICS LIMITED
510(k) number
K103059
Product code
OUJ  
Decision
Substantially Equivalent (SESE)
Decision date
2011-02-24
Date received
2010-10-15
Regulation
892.1570
Classification name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Medical specialty
Radiology
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RON WEINBERGER
Address
24/566 Gardeners Rd. Alexandria, Nsw AU 2015 2015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250434trophon2Nanosonics2025-08-05
K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited2024-09-27
K173865trophon2Nanosonics Limited2018-04-24

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases