SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER— 510(k) K884900
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K884900 for SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER, Substantially Equivalent on 1989-01-13. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code KNW
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.