FDA 510(k)

TrueFit ボルス；TrueFlex ボルス

K番号: K243057 · 2024-10-23

決定日2024-10-23

製品コードMUJ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてAdaptiiv Medical Technologies, Inc.を記載するその他の記録

K260308TrueFit ボルス K241318ノヴァ・サーフェス・アプライアー（ADPT-ONDEM-3DPRT-BRA）

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