FDA 510(k)

TRACOE 喉部压力监测仪

K号: K152778 · 2016-12-21

决定日期2016-12-21

产品代码BSK

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决定实质等同

器械摘要

TRACOE Cuff Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K152778. 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 TRACOE Cuff Pressure Monitor?

TRACOE Cuff Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K152778.

When did TRACOE Cuff Pressure Monitor receive FDA 510(k) clearance?

TRACOE Cuff Pressure Monitor received FDA 510(k) clearance on 2016-12-21, under 510(k) number K152778.

Who is the listed applicant for TRACOE Cuff Pressure Monitor?

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

What is the FDA product code for TRACOE Cuff Pressure Monitor?

The FDA product code for TRACOE Cuff Pressure Monitor is BSK.

列明Tracoe Medical GmbH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。

K203362TRACOE vario K172720TRACOE silcosoft 气管切开管 K152865TRACOE smart 喉部压力管理器

官方来源

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