FDA 510(k)

RxSight 插入装置

K号: K181401 · 2018-07-26

决定日期2018-07-26

产品代码MSS

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决定实质等同

器械摘要

RxSight Insertion Device is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181401. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RxSight Insertion Device?

RxSight Insertion Device is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Rxsight, Inc.. The 510(k) number is K181401.

When did RxSight Insertion Device receive FDA 510(k) clearance?

RxSight Insertion Device received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181401.

Who is the listed applicant for RxSight Insertion Device?

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

What is the FDA product code for RxSight Insertion Device?

The FDA product code for RxSight Insertion Device is MSS.

列明Rxsight, 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。

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官方来源

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