FDA 510(k)

ケンダル NPWT 切開管理装置

K番号: K202217 · 2021-06-04

決定日2021-06-04

製品コードOMP

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定Substantially Equivalent

医療機器の概要

Kendall NPWT Incision Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K202217. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Kendall NPWT Incision Management Device?

Kendall NPWT Incision Management Device is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Cardinalhealth. The 510(k) number is K202217.

When did Kendall NPWT Incision Management Device receive FDA 510(k) clearance?

Kendall NPWT Incision Management Device received FDA 510(k) clearance on 2021-06-04, under 510(k) number K202217.

Who is the listed applicant for Kendall NPWT Incision Management Device?

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

What is the FDA product code for Kendall NPWT Incision Management Device?

The FDA product code for Kendall NPWT Incision Management Device is OMP.

申請者としてCardinalhealthを記載するその他の記録

すべての11件のデバイスを表示 →

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。