SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR— 510(k) K993974
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K993974 for SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR, Substantially Equivalent on 2000-02-22. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code MHX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.