FDA 510(k)

リバイブリユースアブル膀胱サポート

K番号: K183468 · 2019-01-25

決定日2019-01-25

製品コードHHW

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

Revive Reusable Bladder Support is the device name listed in this FDA 510(k) record. The listed applicant is Rinovum Subsidiary 2, LLC. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K183468. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Revive Reusable Bladder Support?

Revive Reusable Bladder Support is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Rinovum Subsidiary 2, LLC. The 510(k) number is K183468.

When did Revive Reusable Bladder Support receive FDA 510(k) clearance?

Revive Reusable Bladder Support received FDA 510(k) clearance on 2019-01-25, under 510(k) number K183468.

Who is the listed applicant for Revive Reusable Bladder Support?

The FDA 510(k) record lists Rinovum Subsidiary 2, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revive Reusable Bladder Support?

The FDA product code for Revive Reusable Bladder Support is HHW.

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。

リバイブリユースアブル膀胱サポート

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：HHW）

公式ソース