FDA 510(k)

EasyOne 天空肺功能儀

K 號：K230178 · 2023-10-19

決定日期2023-10-19

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

EasyOne Sky Spirometer 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 2023-10-19 under 510(k) number K230178. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EasyOne Sky Spirometer?

EasyOne Sky Spirometer is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Ndd Medizintechnik AG. The 510(k) number is K230178.

When did EasyOne Sky Spirometer receive FDA 510(k) clearance?

EasyOne Sky Spirometer received FDA 510(k) clearance on 2023-10-19, under 510(k) number K230178.

Who is the listed applicant for EasyOne Sky Spirometer?

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 Sky Spirometer?

The FDA product code for EasyOne Sky Spirometer is BZG.

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。

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相關器械（代碼：BZG）

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。

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官方來源

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