RESPONDER 3000— 510(k) K000638
Substantially EquivalentGe Medical Systems Information Technologies GmbH
FDA 510(k) clearance K000638 for RESPONDER 3000, Substantially Equivalent on 2000-10-30. Applicant: Ge Medical Systems Information Technologies GmbH.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies GmbH
- Product code
- Code MKJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
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.