UROSKOP D1, UROSKOP D2, AND UROSKOP D3— 510(k) K923049
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K923049 for UROSKOP D1, UROSKOP D2, AND UROSKOP D3, Substantially Equivalent on 1992-09-15. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code OWB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.