FDA 510(k)

クレオロボット・セレクト・システム

K番号: K221086 · 2022-11-04

決定日2022-11-04

製品コードQUJ

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

CryoRobot Select System is the device name listed in this FDA 510(k) record. The listed applicant is Tmrw Life Sciences, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K221086. The device is classified under product code QUJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CryoRobot Select System?

CryoRobot Select System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Tmrw Life Sciences, Inc.. The 510(k) number is K221086.

When did CryoRobot Select System receive FDA 510(k) clearance?

CryoRobot Select System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K221086.

Who is the listed applicant for CryoRobot Select System?

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

What is the FDA product code for CryoRobot Select System?

The FDA product code for CryoRobot Select System is QUJ.

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