FDA 510(k)

EmBody System

K号: K183450 · 2019-06-20

决定日期2019-06-20

产品代码PBX

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决定实质等同

器械摘要

EmBody System is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K183450. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EmBody System?

EmBody System is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K183450.

When did EmBody System receive FDA 510(k) clearance?

EmBody System received FDA 510(k) clearance on 2019-06-20, under 510(k) number K183450.

Who is the listed applicant for EmBody System?

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

What is the FDA product code for EmBody System?

The FDA product code for EmBody System is PBX.

列明Inmode MD , 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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