FDA 510(k)

骨視圖

K 號：K212365 · 2022-03-01

決定日期2022-03-01

產品代碼QBS

諮詢委員會RA

決定相當於

器材摘要

BoneView is the device name listed in this FDA 510(k) record. The listed applicant is Gleamer. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K212365. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BoneView?

BoneView is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Gleamer. The 510(k) number is K212365.

When did BoneView receive FDA 510(k) clearance?

BoneView received FDA 510(k) clearance on 2022-03-01, under 510(k) number K212365.

Who is the listed applicant for BoneView?

FDA 510(k) 記錄將 Gleamer 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BoneView?

The FDA product code for BoneView is QBS.

其他以 Gleamer 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：QBS）

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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