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FDA 510(k)

Geonic 鼻吸器,Geonic 鼻清洁器

K号: K220126 · 2023-02-02

决定日期2023-02-02
产品代码BTA
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Geonic Nasal Aspirator, Geonic Nasal Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Geon Corporation. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K220126. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Geonic Nasal Aspirator, Geonic Nasal Cleaner?

Geonic Nasal Aspirator, Geonic Nasal Cleaner is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Geon Corporation. The 510(k) number is K220126.

When did Geonic Nasal Aspirator, Geonic Nasal Cleaner receive FDA 510(k) clearance?

Geonic Nasal Aspirator, Geonic Nasal Cleaner received FDA 510(k) clearance on 2023-02-02, under 510(k) number K220126.

Who is the listed applicant for Geonic Nasal Aspirator, Geonic Nasal Cleaner?

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

What is the FDA product code for Geonic Nasal Aspirator, Geonic Nasal Cleaner?

The FDA product code for Geonic Nasal Aspirator, Geonic Nasal Cleaner is BTA.

相关临床试验

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。

列明Geon Corporation为申报人的其他记录

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。

相关器械(代码:BTA)

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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