FDA 510(k)

BonOs HV, BonOs MV, BonOs LV

K 號：K210120 · 2021-03-19

決定日期2021-03-19

產品代碼LOD

諮詢委員會或

決定相當於

器材摘要

BonOs HV, BonOs MV, BonOs LV is the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K210120. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BonOs HV, BonOs MV, BonOs LV?

BonOs HV, BonOs MV, BonOs LV is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Osartis GmbH. The 510(k) number is K210120.

When did BonOs HV, BonOs MV, BonOs LV receive FDA 510(k) clearance?

BonOs HV, BonOs MV, BonOs LV received FDA 510(k) clearance on 2021-03-19, under 510(k) number K210120.

Who is the listed applicant for BonOs HV, BonOs MV, BonOs LV?

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

What is the FDA product code for BonOs HV, BonOs MV, BonOs LV?

The FDA product code for BonOs HV, BonOs MV, BonOs LV is LOD.

其他以 Osartis GmbH 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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