Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert— 510(k) K241989

Substantially Equivalent

Cercare Medical A/S

FDA 510(k) clearance K241989 for Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert, Substantially Equivalent on 2024-12-06. 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 C, DK
Download summary PDFView on FDA.gov ↗

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.