FDA 510(k)

我的TAP2

K号: K181482 · 2018-08-31

决定日期2018-08-31

产品代码LRK

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决定实质等同

器械摘要

myTAP2 is the device name listed in this FDA 510(k) record. The listed applicant is Airway Management, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K181482. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the myTAP2?

myTAP2 is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Airway Management, Inc.. The 510(k) number is K181482.

When did myTAP2 receive FDA 510(k) clearance?

myTAP2 received FDA 510(k) clearance on 2018-08-31, under 510(k) number K181482.

Who is the listed applicant for myTAP2?

The FDA 510(k) record lists Airway Management, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for myTAP2?

The FDA product code for myTAP2 is LRK.

列明Airway Management, Inc.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。

K160239TAP 3，TAP 1

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。