PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000— 510(k) K051367
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K051367 for PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000, Substantially Equivalent on 2005-06-20. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code MHX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tampa, FL, 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.