MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM— 510(k) K042177
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K042177 for MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM, Substantially Equivalent on 2004-08-27. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.