FDA 510(k)

CT3000Pro

K番号: K212830 · 2021-12-21

決定日2021-12-21

製品コードFEN

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

CT3000Pro is the device name listed in this FDA 510(k) record. The listed applicant is Srs Medical. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K212830. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CT3000Pro?

CT3000Pro is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Srs Medical. The 510(k) number is K212830.

When did CT3000Pro receive FDA 510(k) clearance?

CT3000Pro received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212830.

Who is the listed applicant for CT3000Pro?

The FDA 510(k) record lists Srs Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT3000Pro?

The FDA product code for CT3000Pro is FEN.

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。