FDA 510(k)

EAGLE EDGE AXR90 和 AXR120

K号: K210820 · 2021-08-10

申请人Alliage S/A Industrias Medico Odontológica

决定日期2021-08-10

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

EAGLE EDGE AXR90 and AXR120 is the device name listed in this FDA 510(k) record. The listed applicant is Alliage S/A Industrias Medico Odontológica. It received FDA 510(k) clearance on 2021-08-10 under 510(k) number K210820. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EAGLE EDGE AXR90 and AXR120?

EAGLE EDGE AXR90 and AXR120 is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Alliage S/A Industrias Medico Odontológica. The 510(k) number is K210820.

When did EAGLE EDGE AXR90 and AXR120 receive FDA 510(k) clearance?

EAGLE EDGE AXR90 and AXR120 received FDA 510(k) clearance on 2021-08-10, under 510(k) number K210820.

Who is the listed applicant for EAGLE EDGE AXR90 and AXR120?

The FDA 510(k) record lists Alliage S/A Industrias Medico Odontológica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EAGLE EDGE AXR90 and AXR120?

The FDA product code for EAGLE EDGE AXR90 and AXR120 is OAS.

列明Alliage S/A Industrias Medico Odontológica为申报人的其他记录

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