Ashvins— 510(k) K200132

Substantially Equivalent

Medicalcommunications GmbH

FDA 510(k) clearance K200132 for Ashvins, Substantially Equivalent on 2020-02-18. Applicant: Medicalcommunications GmbH.

Clearance details

Applicant
Medicalcommunications GmbH
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Heidelberg, DE
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.