COR12 ECG— 510(k) K183369
Substantially EquivalentCorscience GmbH & Co.
FDA 510(k) clearance K183369 for COR12 ECG, Substantially Equivalent on 2018-12-28. Applicant: Corscience GmbH & Co..
Clearance details
- Applicant
- Corscience GmbH & Co.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlangen, DE
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.