CardioDay V2.5— 510(k) K162023
Substantially EquivalentGetemed Medizin- Und Informationstechnik AG
FDA 510(k) clearance K162023 for CardioDay V2.5, Substantially Equivalent on 2017-03-24. Applicant: Getemed Medizin- Und Informationstechnik AG.
Clearance details
- Applicant
- Getemed Medizin- Und Informationstechnik AG
- Product code
- Code DQK
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Teltow, DE
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.