The following data is part of a premarket notification filed by Nanosonics Limited with the FDA for Trophon2.
| Device ID | K173865 |
| 510k Number | K173865 |
| Device Name: | Trophon2 |
| Classification | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Applicant | Nanosonics Limited 14 Mars Road Lane Cove, AU 2066 |
| Contact | Ruth Cremin |
| Correspondent | Ruth Cremin Nanosonics Limited 14 Mars Road Lane Cove, AU 2066 |
| Product Code | OUJ |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09350855000184 | K173865 | 000 |