FDA 510(k)

XactTrace 单次使用呼吸努力带系统

K号: K173793 · 2019-03-01

决定日期2019-03-01

产品代码MNR

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决定实质等同

器械摘要

XactTrace Single Use Respiratory Effort Belt System is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K173793. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XactTrace Single Use Respiratory Effort Belt System?

XactTrace Single Use Respiratory Effort Belt System is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Embla Systems. The 510(k) number is K173793.

When did XactTrace Single Use Respiratory Effort Belt System receive FDA 510(k) clearance?

XactTrace Single Use Respiratory Effort Belt System received FDA 510(k) clearance on 2019-03-01, under 510(k) number K173793.

Who is the listed applicant for XactTrace Single Use Respiratory Effort Belt System?

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

What is the FDA product code for XactTrace Single Use Respiratory Effort Belt System?

The FDA product code for XactTrace Single Use Respiratory Effort Belt System is MNR.

列明Embla Systems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。

K180001一次性成人呼吸传感器，一次性小型成人/儿童呼吸传感器，一次性早产儿呼吸传感器，一次性婴儿呼吸传感器 K172703一次性快接电极 K163617REMbrandt K162140RemLogic K153353SANDMAN ELITE

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。