FDA 510(k)

FirstSense 乳腺检查

K号: K160573 · 2016-06-01

决定日期2016-06-01

产品代码LHQ

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决定实质等同

器械摘要

FirstSense Breast Exam is the device name listed in this FDA 510(k) record. The listed applicant is First Sense Medical, LLC. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K160573. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FirstSense Breast Exam?

FirstSense Breast Exam is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is First Sense Medical, LLC. The 510(k) number is K160573.

When did FirstSense Breast Exam receive FDA 510(k) clearance?

FirstSense Breast Exam received FDA 510(k) clearance on 2016-06-01, under 510(k) number K160573.

Who is the listed applicant for FirstSense Breast Exam?

The FDA 510(k) record lists First Sense Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FirstSense Breast Exam?

The FDA product code for FirstSense Breast Exam is LHQ.

列明First Sense Medical, LLC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。

K162767Sentinel BreastScan II System

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。