CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System— 510(k) K231870
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K231870 for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System, Substantially Equivalent on 2023-12-13. Applicant: Ge Medical Systems Information Technologies, Inc..
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code DQK
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.