FDA 510(k)

Lux 35 探测器

K号: K203159 · 2020-12-02

决定日期2020-12-02

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Lux 35 Detector is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K203159. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lux 35 Detector?

Lux 35 Detector is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Carestream Health. The 510(k) number is K203159.

When did Lux 35 Detector receive FDA 510(k) clearance?

Lux 35 Detector received FDA 510(k) clearance on 2020-12-02, under 510(k) number K203159.

Who is the listed applicant for Lux 35 Detector?

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

What is the FDA product code for Lux 35 Detector?

The FDA product code for Lux 35 Detector is MQB.

列明Carestream Health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。

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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。