510(k) K250434
- Device
- trophon2
- Applicant
- Nanosonics
- 510(k) number
- K250434
- Product code
- OUJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-05
- Date received
- 2025-02-14
- Regulation
- 892.1570
- Classification name
- High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nancy Kaiser
- Address
- 7-11 Talavera Rd. Macquarie Park AU 2113 2113
FDA Registration Numbers#
- 3008894376
- 3006564498
- 1831301