FDA 510(k)

Clearum HS 家族，Clearum HS 模型：HS 13、HS 15、HS 17、HS 20、HS 22

K 號：K193542 · 2020-10-08

決定日期2020-10-08

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Srl. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K193542. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Bellco Srl. The 510(k) number is K193542.

When did Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 receive FDA 510(k) clearance?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 received FDA 510(k) clearance on 2020-10-08, under 510(k) number K193542.

Who is the listed applicant for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

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

What is the FDA product code for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

The FDA product code for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is KDI.

其他以 Bellco Srl 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：KDI）

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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