FDA 510(k)

AVA (Augmented Vascular Analysis)

K番号: K201369 · 2020-09-16

決定日2020-09-16

製品コードLLZ

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

AVA (Augmented Vascular Analysis) is the device name listed in this FDA 510(k) record. The listed applicant is See-Mode Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K201369. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AVA (Augmented Vascular Analysis)?

AVA (Augmented Vascular Analysis) is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is See-Mode Technologies Pte, Ltd.. The 510(k) number is K201369.

When did AVA (Augmented Vascular Analysis) receive FDA 510(k) clearance?

AVA (Augmented Vascular Analysis) received FDA 510(k) clearance on 2020-09-16, under 510(k) number K201369.

Who is the listed applicant for AVA (Augmented Vascular Analysis)?

The FDA 510(k) record lists See-Mode Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVA (Augmented Vascular Analysis)?

The FDA product code for AVA (Augmented Vascular Analysis) is LLZ.

申請者としてSee-Mode Technologies Pte, Ltd.を記載するその他の記録

K240697See-Mode 拡張報告ツール、甲状腺（SMART-T）

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