FDA 510(k)

VR101 润滑用陰道リング

K番号: K203377 · 2021-05-20

決定日2021-05-20

製品コードQPD

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

VR101 Lubricating Intravaginal Ring is the device name listed in this FDA 510(k) record. The listed applicant is J3 Bioscience, Inc.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203377. The device is classified under product code QPD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the VR101 Lubricating Intravaginal Ring?

VR101 Lubricating Intravaginal Ring is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is J3 Bioscience, Inc.. The 510(k) number is K203377.

When did VR101 Lubricating Intravaginal Ring receive FDA 510(k) clearance?

VR101 Lubricating Intravaginal Ring received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203377.

Who is the listed applicant for VR101 Lubricating Intravaginal Ring?

The FDA 510(k) record lists J3 Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VR101 Lubricating Intravaginal Ring?

The FDA product code for VR101 Lubricating Intravaginal Ring is QPD.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

医療機器の概要

よくある質問

関連する臨床試験

公式ソース