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510(k) K173865

Device
Trophon2
Applicant
Nanosonics Limited
510(k) number
K173865
Product code
OUJ  
Decision
Substantially Equivalent (SESE)
Decision date
2018-04-24
Date received
2017-12-20
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
Ruth Cremin
Address
14 Mars Rd. Lane Cove AU 2066 2066

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
K103059TROPHONNanosonics Limited2011-02-24

Legacy Summary#

summary

FDA Review#

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