SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)— 510(k) K952054
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K952054 for SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960), Substantially Equivalent on 1996-06-07. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code DSI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
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.