FDA 510(k)

AnapnoGuard 100呼吸监护系统

K号: K150157 · 2016-02-16

决定日期2016-02-16

产品代码BSK

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决定实质等同

器械摘要

AnapnoGuard 100 Respiratory Guard System is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K150157. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AnapnoGuard 100 Respiratory Guard System?

AnapnoGuard 100 Respiratory Guard System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K150157.

When did AnapnoGuard 100 Respiratory Guard System receive FDA 510(k) clearance?

AnapnoGuard 100 Respiratory Guard System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K150157.

Who is the listed applicant for AnapnoGuard 100 Respiratory Guard System?

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

What is the FDA product code for AnapnoGuard 100 Respiratory Guard System?

The FDA product code for AnapnoGuard 100 Respiratory Guard System is BSK.

列明Hospitech Respiration , 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。

K221477AG100s K180991AG 100s

官方来源

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