FDA 510(k)

9100 型號肺功能測試/氣道內視鏡設備

K 號：K221030 · 2022-07-15

決定日期2022-07-15

產品代碼BTY

諮詢委員會AN

決定相當於

器材摘要

Model 9100 PFT/DICO is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221030. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Model 9100 PFT/DICO?

Model 9100 PFT/DICO is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K221030.

When did Model 9100 PFT/DICO receive FDA 510(k) clearance?

Model 9100 PFT/DICO received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221030.

Who is the listed applicant for Model 9100 PFT/DICO?

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

What is the FDA product code for Model 9100 PFT/DICO?

The FDA product code for Model 9100 PFT/DICO is BTY.

其他以 Vitalograph Ireland, Ltd. 為申請人之記錄

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相關器械（代碼：BTY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260242CPETWise 平臺Medibyt , Ltd.K242809Ascent 心肺診斷軟體Medical Graphics Corporation K223629SpіroSphere，SpіroSphereECG，CardіoSphereEresearchtechnology GmbH K231561肺功能測試儀，型號：A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus代謝監測器Virtus Technology Aps K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH

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