EAGLE EDGE AXR90 and AXR120— 510(k) K210820

Name: FDA 510(k) clearance K210820
Creator: U.S. Food and Drug Administration
Published: 2021-08-10

Substantially Equivalent

Alliage S/A Industrias Medico Odontológica

FDA 510(k) clearance K210820 for EAGLE EDGE AXR90 and AXR120, Substantially Equivalent on 2021-08-10. Applicant: Alliage S/A Industrias Medico Odontológica. Device class: 2.

Clearance details

Applicant: Alliage S/A Industrias Medico Odontológica
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
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 ↗

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