FDA 510(k)

CONVIVO 適用於實體病理的套件

K 號：K211156 · 2021-12-29

決定日期2021-12-29

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CONVIVO In Vivo Pathology Suite is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2021-12-29 under 510(k) number K211156. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CONVIVO In Vivo Pathology Suite?

CONVIVO In Vivo Pathology Suite is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K211156.

When did CONVIVO In Vivo Pathology Suite receive FDA 510(k) clearance?

CONVIVO In Vivo Pathology Suite received FDA 510(k) clearance on 2021-12-29, under 510(k) number K211156.

Who is the listed applicant for CONVIVO In Vivo Pathology Suite?

FDA 510(k) 記錄將 Carl Zeiss Meditec, AG 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CONVIVO In Vivo Pathology Suite?

The FDA product code for CONVIVO In Vivo Pathology Suite is LLZ.

其他以 Carl Zeiss Meditec, AG 為申請人之記錄

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相關器械（代碼：LLZ）

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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