FDA 510(k)

RP Lite 760R

K号: K163280 · 2017-01-27

决定日期2017-01-27

产品代码IRP

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决定实质等同

器械摘要

RP Lite 760R is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K163280. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RP Lite 760R?

RP Lite 760R is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Mego Afek AC , Ltd.. The 510(k) number is K163280.

When did RP Lite 760R receive FDA 510(k) clearance?

RP Lite 760R received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163280.

Who is the listed applicant for RP Lite 760R?

The FDA 510(k) record lists Mego Afek AC , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RP Lite 760R?

The FDA product code for RP Lite 760R is IRP.

列明Mego Afek AC , Ltd.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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相关器械（代码：IRP）

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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