FDA 510(k)

Cetus系统，Cetus探头

K号: K170183 · 2017-09-27

决定日期2017-09-27

产品代码HQE

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决定实质等同

器械摘要

Cetus system, Cetus probe is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K170183. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cetus system, Cetus probe?

Cetus system, Cetus probe is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K170183.

When did Cetus system, Cetus probe receive FDA 510(k) clearance?

Cetus system, Cetus probe received FDA 510(k) clearance on 2017-09-27, under 510(k) number K170183.

Who is the listed applicant for Cetus system, Cetus probe?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cetus system, Cetus probe?

The FDA product code for Cetus system, Cetus probe is HQE.

列明A.R.C Laser 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。

K220531FOX 810, FOX 980 K192272狼445nm K161403A.R.C. 激光手术光纤和探头

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