FDA 510(k)

27HJ713S

K号: K170899 · 2017-05-30

决定日期2017-05-30

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

27HJ713S is the device name listed in this FDA 510(k) record. The listed applicant is Lg Electronics. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K170899. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 27HJ713S?

27HJ713S is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Lg Electronics. The 510(k) number is K170899.

When did 27HJ713S receive FDA 510(k) clearance?

27HJ713S received FDA 510(k) clearance on 2017-05-30, under 510(k) number K170899.

Who is the listed applicant for 27HJ713S?

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

What is the FDA product code for 27HJ713S?

The FDA product code for 27HJ713S is GCJ.

列明Lg Electronics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。

K191188ASHK100G K18033217HK700G-W K170984LG BEAUTY LED MASK

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

在 FDA 数据库中查看 →

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。