FDA 510(k)

VisionAir Patient-Specific Airway Stent

K番号: K213969 · 2022-10-07

決定日2022-10-07

製品コードNWA

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

決定大幅同等

医療機器の概要

VisionAir Patient-Specific Airway Stent is the device name listed in this FDA 510(k) record. The listed applicant is New Cos Inc. Dba Visionair Solutions. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K213969. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the VisionAir Patient-Specific Airway Stent?

VisionAir Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is New Cos Inc. Dba Visionair Solutions. The 510(k) number is K213969.

When did VisionAir Patient-Specific Airway Stent receive FDA 510(k) clearance?

VisionAir Patient-Specific Airway Stent received FDA 510(k) clearance on 2022-10-07, under 510(k) number K213969.

Who is the listed applicant for VisionAir Patient-Specific Airway Stent?

The FDA 510(k) record lists New Cos Inc. Dba Visionair Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisionAir Patient-Specific Airway Stent?

The FDA product code for VisionAir Patient-Specific Airway Stent is NWA.

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。

VisionAir Patient-Specific Airway Stent

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：NWA）

公式ソース