FDA · official record K210820Substantially Equivalent

EAGLE EDGE AXR90 and AXR120

Name: EAGLE EDGE AXR90 and AXR120 — FDA K210820
Creator: Alliage S/A Industrias Medico Odontológica
Keywords: EAGLE EDGE AXR90 and AXR120, EAGLE EDGE AXR90 and AXR120, K210820, OAS, FDA

United StatesOASAlliage S/A Industrias Medico Odontológica

Verified

Official record identity

FDA application number: K210820
Decision date: August 10, 2021
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Alliage S/A Industrias Medico Odontológica

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2021-03-19
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.