FDA 510(k)

斯匹羅特拉科

K 號：K201562 · 2020-10-14

決定日期2020-10-14

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

Spirotrac 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 2020-10-14 under 510(k) number K201562. 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 Spirotrac?

Spirotrac is a medical device that received FDA 510(k) clearance on 2020-10-14. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K201562.

When did Spirotrac receive FDA 510(k) clearance?

Spirotrac received FDA 510(k) clearance on 2020-10-14, under 510(k) number K201562.

Who is the listed applicant for Spirotrac?

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 Spirotrac?

The FDA product code for Spirotrac is BZG.

其他以 Vitalograph Ireland, Ltd. 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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