FDA 510(k)

INDIBA COMPACT devices

K号: K243164 · 2024-11-20

决定日期2024-11-20

产品代码PBX

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决定实质等同

器械摘要

INDIBA COMPACT devices is the device name listed in this FDA 510(k) record. The listed applicant is Indiba S. A. U.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K243164. 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 INDIBA COMPACT devices?

INDIBA COMPACT devices is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Indiba S. A. U.. The 510(k) number is K243164.

When did INDIBA COMPACT devices receive FDA 510(k) clearance?

INDIBA COMPACT devices received FDA 510(k) clearance on 2024-11-20, under 510(k) number K243164.

Who is the listed applicant for INDIBA COMPACT devices?

The FDA 510(k) record lists Indiba S. A. U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDIBA COMPACT devices?

The FDA product code for INDIBA COMPACT devices is PBX.

列明Indiba S. A. U.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。

K241107Indiba 热疗射频深部护理设备（深部护理 IDC0409/EVONY）；Indiba 热疗射频激活设备（激活 ACT0309/CT9）K243139Reverso Pro System

官方来源

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