FDA 510(k)

EasyOne Pro 呼吸分析系統

K 號：K161534 · 2017-02-22

決定日期2017-02-22

產品代碼BTY

諮詢委員會AN

決定相當於

器材摘要

EasyOne Pro Respiratory Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Ndd Medizintechnik AG. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K161534. 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 EasyOne Pro Respiratory Analysis System?

EasyOne Pro Respiratory Analysis System is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Ndd Medizintechnik AG. The 510(k) number is K161534.

When did EasyOne Pro Respiratory Analysis System receive FDA 510(k) clearance?

EasyOne Pro Respiratory Analysis System received FDA 510(k) clearance on 2017-02-22, under 510(k) number K161534.

Who is the listed applicant for EasyOne Pro Respiratory Analysis System?

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

What is the FDA product code for EasyOne Pro Respiratory Analysis System?

The FDA product code for EasyOne Pro Respiratory Analysis System is BTY.

其他以 Ndd Medizintechnik AG 為申請人之記錄

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。

K230178EasyOne 天空肺功能儀 K221250EasyOne 過濾器 K161536EasyOne空氣肺功能儀

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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