FDA 510(k)

泰瑟拉-k SC 系統

K 號：K242928 · 2025-04-10

決定日期2025-04-10

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Tesera-k SC System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K242928. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tesera-k SC System?

Tesera-k SC System is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K242928.

When did Tesera-k SC System receive FDA 510(k) clearance?

Tesera-k SC System received FDA 510(k) clearance on 2025-04-10, under 510(k) number K242928.

Who is the listed applicant for Tesera-k SC System?

FDA 510(k) 記錄將京瓷醫療技術股份有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Tesera-k SC System?

The FDA product code for Tesera-k SC System is OVE.

其他以 Kyocera Medical Technologies, Inc. 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：OVE）

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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