FDA 510(k)

Vivo 45 LS

K 號：K193586 · 2021-01-27

決定日期2021-01-27

產品代碼NOU

諮詢委員會AN

決定相當於

器材摘要

Vivo 45 LS is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2021-01-27 under 510(k) number K193586. The device is classified under product code NOU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vivo 45 LS?

Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2021-01-27. The listed applicant is Breas Medical AB. The 510(k) number is K193586.

When did Vivo 45 LS receive FDA 510(k) clearance?

Vivo 45 LS received FDA 510(k) clearance on 2021-01-27, under 510(k) number K193586.

Who is the listed applicant for Vivo 45 LS?

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

What is the FDA product code for Vivo 45 LS?

The FDA product code for Vivo 45 LS is NOU.

其他以 Breas Medical AB 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。

K242485每物 K242438清朗 K233452Vivo 45 LS K240778Vivo 1, Vivo 2 K240779Vivo 3 K160481Vivo 60

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相關器械（代碼：NOU）

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。

K233452Vivo 45 LSBreas Medical AB K160481Vivo 60Breas Medical AB

官方來源

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