FDA 510(k)

Change Healthcare カーディオロジー

K番号: K212528 · 2021-10-18

決定日2021-10-18

製品コードLLZ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Change Healthcare Cardiology is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Israel , Ltd.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K212528. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Change Healthcare Cardiology?

Change Healthcare Cardiology is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Change Healthcare Israel , Ltd.. The 510(k) number is K212528.

When did Change Healthcare Cardiology receive FDA 510(k) clearance?

Change Healthcare Cardiology received FDA 510(k) clearance on 2021-10-18, under 510(k) number K212528.

Who is the listed applicant for Change Healthcare Cardiology?

The FDA 510(k) record lists Change Healthcare Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Change Healthcare Cardiology?

The FDA product code for Change Healthcare Cardiology is LLZ.

申請者としてChange Healthcare Israel , Ltd.を記載するその他の記録

K230881Change Healthcare カーディオロジーヒモダイナミクス™K181080メッコーソン・カーディオロジー

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。