K210820

Substantially Equivalent

EAGLE EDGE AXR90 and AXR120

Applicant: Alliage S/A Industrias Medico Odontológica
Product code: OAS
Advisory panel: Radiology
Date received: 2021-03-19
Decision date: 2021-08-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Recreio Anhanguera, BR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.