SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE— 510(k) K071073
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K071073 for SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE, Substantially Equivalent on 2007-05-11. 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
- Milwaukee, WI, 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.