Infinity / Infinity Cross Flex Dental Systems
K号: K180935 · 2020-02-05
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决定日期2020-02-05
产品代码EIA
咨询委员会DE
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决定实质等同
器械摘要
Infinity / Infinity Cross Flex Dental Systems is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Industria E Comercio S.A.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K180935. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Infinity / Infinity Cross Flex Dental Systems?
Infinity / Infinity Cross Flex Dental Systems is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Olsen Industria E Comercio S.A.. The 510(k) number is K180935.
When did Infinity / Infinity Cross Flex Dental Systems receive FDA 510(k) clearance?
Infinity / Infinity Cross Flex Dental Systems received FDA 510(k) clearance on 2020-02-05, under 510(k) number K180935.
Who is the listed applicant for Infinity / Infinity Cross Flex Dental Systems?
The FDA 510(k) record lists Olsen Industria E Comercio S.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infinity / Infinity Cross Flex Dental Systems?
The FDA product code for Infinity / Infinity Cross Flex Dental Systems is EIA.
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相关器械（代码：EIA）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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