TROPHON
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
NANOSONICS LIMITED
The following data is part of a premarket notification filed by Nanosonics Limited with the FDA for Trophon.
Pre-market Notification Details
| Device ID | K103059 |
| 510k Number | K103059 |
| Device Name: | TROPHON |
| Classification | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Applicant | NANOSONICS LIMITED 24/566 GARDENERS ROAD Alexandria, Nsw, AU 2015 |
| Contact | Ron Weinberger |
| Correspondent | Ron Weinberger NANOSONICS LIMITED 24/566 GARDENERS ROAD Alexandria, Nsw, AU 2015 |
| Product Code | OUJ |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-15 |
| Decision Date | 2011-02-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09350855000078 | K103059 | 000 |
| 09350855000139 | K103059 | 000 |
| 09350855000092 | K103059 | 000 |
| 09350855000115 | K103059 | 000 |
| 09350855000108 | K103059 | 000 |
| 09350855000566 | K103059 | 000 |
Trademark Results [TROPHON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TROPHON 79134830 4611734 Live/Registered |
Nanosonics Limited 2013-07-18 |
 TROPHON 79053848 3728492 Live/Registered |
Nanosonics Limited 2008-03-11 |
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