GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11— 510(k) K000645
Substantially EquivalentGeneral Electric Medical Systems Information Techn
FDA 510(k) clearance K000645 for GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11, Substantially Equivalent on 2000-05-24. Applicant: General Electric Medical Systems Information Techn.
Clearance details
- Applicant
- General Electric Medical Systems Information Techn
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sugarland, TX, 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.