trophon2— 510(k) K173865
Substantially EquivalentNanosonics Limited
FDA 510(k) clearance K173865 for trophon2, Substantially Equivalent on 2018-04-24. Applicant: Nanosonics Limited. Device class: 2.
Clearance details
- Applicant
- Nanosonics Limited
- Product code
- Code OUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lane Cove, AU
Recent devices under product code OUJ
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view allAdverse events under product code OUJ
product code OUJ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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