K251022

Substantially Equivalent

3D-SHAPER

Applicant
3D-Shaper Medical S.L
Product code
KGI
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Barcelona, ES
Download summary PDF View on FDA.gov ↗

Adverse events under product code KGI

product code KGI
Other
1
Total
1

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.