SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER— 510(k) K081148
Substantially EquivalentSiemens Medical Solutions USA, Inc., Ultrasound DI
FDA 510(k) clearance K081148 for SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER, Substantially Equivalent on 2008-12-22. Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.