FDA 510(k)

iCOquit® 烟雾检测仪®

K号: K211918 · 2021-12-21

决定日期2021-12-21

产品代码CCJ

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决定实质等同

器械摘要

iCOquit® Smokerlyzer® is the device name listed in this FDA 510(k) record. The listed applicant is Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K211918. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iCOquit® Smokerlyzer®?

iCOquit® Smokerlyzer® is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Bedfont Scientific, Ltd.. The 510(k) number is K211918.

When did iCOquit® Smokerlyzer® receive FDA 510(k) clearance?

iCOquit® Smokerlyzer® received FDA 510(k) clearance on 2021-12-21, under 510(k) number K211918.

Who is the listed applicant for iCOquit® Smokerlyzer®?

The FDA 510(k) record lists Bedfont Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCOquit® Smokerlyzer®?

The FDA product code for iCOquit® Smokerlyzer® is CCJ.

列明Bedfont Scientific, Ltd.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。

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官方来源

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