FDA 510(k)

Shape-HF 心肺測試系統

K 號：K150888 · 2016-01-21

決定日期2016-01-21

產品代碼BTY

諮詢委員會AN

決定相當於

器材摘要

Shape-HF Cardiopulmonary Testing System is the device name listed in this FDA 510(k) record. The listed applicant is Shape Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K150888. 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 Shape-HF Cardiopulmonary Testing System?

Shape-HF Cardiopulmonary Testing System is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Shape Medical Systems, Inc.. The 510(k) number is K150888.

When did Shape-HF Cardiopulmonary Testing System receive FDA 510(k) clearance?

Shape-HF Cardiopulmonary Testing System received FDA 510(k) clearance on 2016-01-21, under 510(k) number K150888.

Who is the listed applicant for Shape-HF Cardiopulmonary Testing System?

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

What is the FDA product code for Shape-HF Cardiopulmonary Testing System?

The FDA product code for Shape-HF Cardiopulmonary Testing System is BTY.

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 K2210309100 型號肺功能測試/氣道內視鏡設備Vitalograph Ireland, Ltd.

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：BTY）

官方來源