FDA 510(k)

TrueFit 注射剂；TrueFlex 注射剂

K号: K243057 · 2024-10-23

决定日期2024-10-23

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

TrueFit Bolus; TrueFlex Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Adaptiiv Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K243057. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TrueFit Bolus; TrueFlex Bolus?

TrueFit Bolus; TrueFlex Bolus is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is Adaptiiv Medical Technologies, Inc.. The 510(k) number is K243057.

When did TrueFit Bolus; TrueFlex Bolus receive FDA 510(k) clearance?

TrueFit Bolus; TrueFlex Bolus received FDA 510(k) clearance on 2024-10-23, under 510(k) number K243057.

Who is the listed applicant for TrueFit Bolus; TrueFlex Bolus?

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

What is the FDA product code for TrueFit Bolus; TrueFlex Bolus?

The FDA product code for TrueFit Bolus; TrueFlex Bolus is MUJ.

列明Adaptiiv Medical Technologies, 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。

K260308TrueFit 注射剂 K241318Nova表面敷贴器（ADPT-ONDEM-3DPRT-BRA）

官方来源

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