FDA 510(k)

陰道触覚超音波画像装置

K番号: K231875 · 2024-02-22

決定日2024-02-22

製品コードHIR

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Vaginal Tactile Ultrasound Imager is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Tactile Imaging, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K231875. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Vaginal Tactile Ultrasound Imager?

Vaginal Tactile Ultrasound Imager is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Advanced Tactile Imaging, Inc.. The 510(k) number is K231875.

When did Vaginal Tactile Ultrasound Imager receive FDA 510(k) clearance?

Vaginal Tactile Ultrasound Imager received FDA 510(k) clearance on 2024-02-22, under 510(k) number K231875.

Who is the listed applicant for Vaginal Tactile Ultrasound Imager?

The FDA 510(k) record lists Advanced Tactile Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vaginal Tactile Ultrasound Imager?

The FDA product code for Vaginal Tactile Ultrasound Imager is HIR.

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陰道触覚超音波画像装置

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：HIR）

公式ソース