FDA 510(k)

DEFINE 系统 (AG612444A)

K号: K242598 · 2024-11-14

决定日期2024-11-14

产品代码PBX

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决定实质等同

器械摘要

DEFINE System (AG612444A) is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K242598. 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 DEFINE System (AG612444A)?

DEFINE System (AG612444A) is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is InMode , Ltd.. The 510(k) number is K242598.

When did DEFINE System (AG612444A) receive FDA 510(k) clearance?

DEFINE System (AG612444A) received FDA 510(k) clearance on 2024-11-14, under 510(k) number K242598.

Who is the listed applicant for DEFINE System (AG612444A)?

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

What is the FDA product code for DEFINE System (AG612444A)?

The FDA product code for DEFINE System (AG612444A) is PBX.

列明InMode , 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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官方来源

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