FDA 510(k)

SICAT 嵌入式設備 V2.0

K 號：K192348 · 2019-12-04

決定日期2019-12-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

SICAT Implant V2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Sicat GmbH & Co. KG. It received FDA 510(k) clearance on 2019-12-04 under 510(k) number K192348. 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 SICAT Implant V2.0?

SICAT Implant V2.0 is a medical device that received FDA 510(k) clearance on 2019-12-04. The listed applicant is Sicat GmbH & Co. KG. The 510(k) number is K192348.

When did SICAT Implant V2.0 receive FDA 510(k) clearance?

SICAT Implant V2.0 received FDA 510(k) clearance on 2019-12-04, under 510(k) number K192348.

Who is the listed applicant for SICAT Implant V2.0?

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

What is the FDA product code for SICAT Implant V2.0?

The FDA product code for SICAT Implant V2.0 is LLZ.

其他以 Sicat GmbH & Co. KG 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：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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