先锋口腔设备
K号: K161734 · 2016-12-09
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决定日期2016-12-09
产品代码EIA
咨询委员会DE
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器械摘要
Vanguard Dental Unit is the device name listed in this FDA 510(k) record. The listed applicant is Ritter Concept GmbH. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K161734. 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 Vanguard Dental Unit?
Vanguard Dental Unit is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Ritter Concept GmbH. The 510(k) number is K161734.
When did Vanguard Dental Unit receive FDA 510(k) clearance?
Vanguard Dental Unit received FDA 510(k) clearance on 2016-12-09, under 510(k) number K161734.
Who is the listed applicant for Vanguard Dental Unit?
The FDA 510(k) record lists Ritter Concept GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vanguard Dental Unit?
The FDA product code for Vanguard Dental Unit is EIA.
相关临床试验
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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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