Cercare Medical Neurosuite— 510(k) K230016
Substantially EquivalentCercare Medical A/S
FDA 510(k) clearance K230016 for Cercare Medical Neurosuite, Substantially Equivalent on 2023-07-14. Applicant: Cercare Medical A/S.
Clearance details
- Applicant
- Cercare Medical A/S
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aarhus, DK
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.