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FDA 510(k)

SafeAir烟雾抽吸器紧凑型

K号: K182224 · 2019-02-07

决定日期2019-02-07
产品代码FYD
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决定实质等同

器械摘要

SafeAir Smoke Evacuator compact is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K182224. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SafeAir Smoke Evacuator compact?

SafeAir Smoke Evacuator compact is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Lina Medical Aps. The 510(k) number is K182224.

When did SafeAir Smoke Evacuator compact receive FDA 510(k) clearance?

SafeAir Smoke Evacuator compact received FDA 510(k) clearance on 2019-02-07, under 510(k) number K182224.

Who is the listed applicant for SafeAir Smoke Evacuator compact?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeAir Smoke Evacuator compact?

The FDA product code for SafeAir Smoke Evacuator compact is FYD.

相关临床试验

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列明Lina Medical Aps为申报人的其他记录

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相关器械(代码:FYD)

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。

官方来源

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