K103059 is an FDA 510(k) clearance for the TROPHON. This device is classified as a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (Class II - Special Controls, product code OUJ).
Submitted by Nanosonics Limited (Alexandria, Nsw, AU). The FDA issued a Cleared decision on February 24, 2011, 132 days after receiving the submission on October 15, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 892.1570. To Provide High Level Disinfection Of Ultrasound Transducers. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K103059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2010 |
| Decision Date | February 24, 2011 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | OUJ — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |
| Definition | To Provide High Level Disinfection Of Ultrasound Transducers. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |