FDA 510(k)

Sensus TPS 工作站

K号: K182665 · 2019-02-21

决定日期2019-02-21

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

Sensus TPS Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under 510(k) number K182665. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sensus TPS Workstation?

Sensus TPS Workstation is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K182665.

When did Sensus TPS Workstation receive FDA 510(k) clearance?

Sensus TPS Workstation received FDA 510(k) clearance on 2019-02-21, under 510(k) number K182665.

Who is the listed applicant for Sensus TPS Workstation?

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

What is the FDA product code for Sensus TPS Workstation?

The FDA product code for Sensus TPS Workstation is MUJ.

列明Sensus Healthcare, 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。

K190255Sensus Healthcare TVM 气球应用器 K182641Sensus IORT 系统 K173425SRT-100+

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。