FDA 510(k)

RetCam 3；RetCam Shuttle；RetCam便携式

K号: K182263 · 2018-09-07

决定日期2018-09-07

产品代码HKI

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决定实质等同

器械摘要

RetCam 3 ; RetCam Shuttle ; RetCam Portable is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182263. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RetCam 3 ; RetCam Shuttle ; RetCam Portable?

RetCam 3 ; RetCam Shuttle ; RetCam Portable is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Natus Medical Incorporated. The 510(k) number is K182263.

When did RetCam 3 ; RetCam Shuttle ; RetCam Portable receive FDA 510(k) clearance?

RetCam 3 ; RetCam Shuttle ; RetCam Portable received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182263.

Who is the listed applicant for RetCam 3 ; RetCam Shuttle ; RetCam Portable?

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

What is the FDA product code for RetCam 3 ; RetCam Shuttle ; RetCam Portable?

The FDA product code for RetCam 3 ; RetCam Shuttle ; RetCam Portable is HKI.

列明Natus Medical Incorporated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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