SMDIE DEVICE INTERFACING SYSTEM— 510(k) K061590
Substantially EquivalentSiemens Medical Solutions Health Services Corporat
FDA 510(k) clearance K061590 for SMDIE DEVICE INTERFACING SYSTEM, Substantially Equivalent on 2006-06-21. Applicant: Siemens Medical Solutions Health Services Corporat.
Clearance details
- Applicant
- Siemens Medical Solutions Health Services Corporat
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.