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FDA 510(k)

XP1100 RF

K号: K152731 · 2016-07-20

决定日期2016-07-20
产品代码GEI
咨询委员会SU
决定Substantially Equivalent

器械摘要

XP1100 RF is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152731. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XP1100 RF?

XP1100 RF is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is BTL Industries, Inc.. The 510(k) number is K152731.

When did XP1100 RF receive FDA 510(k) clearance?

XP1100 RF received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152731.

Who is the listed applicant for XP1100 RF?

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

What is the FDA product code for XP1100 RF?

The FDA product code for XP1100 RF is GEI.

列明BTL Industries, 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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相关器械(代码:GEI)

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。

官方来源

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