TROPHON
FDA 510(k) clearance K103059 · decided 2011-02-24
Clearance details
- K-number
- K103059
- Device name
- TROPHON
- Applicant
- Nanosonics Limited
- Decision
- Substantially Equivalent
- Date received
- 2010-10-15
- Decision date
- 2011-02-24
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- OUJ
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Alexandria, Nsw, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Tr recall (Z-1602-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |