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FDA 510(k)

CustoMED 觀察器

K 號:K260116 · 2026-06-03

決定日期2026-06-03
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

CustoMED Viewer is the device name listed in this FDA 510(k) record. The listed applicant is CustoMED , Ltd.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260116. 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 CustoMED Viewer?

CustoMED Viewer is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is CustoMED , Ltd.. The 510(k) number is K260116.

When did CustoMED Viewer receive FDA 510(k) clearance?

CustoMED Viewer received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260116.

Who is the listed applicant for CustoMED Viewer?

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

What is the FDA product code for CustoMED Viewer?

The FDA product code for CustoMED Viewer is LLZ.

相關臨床試驗

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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。

官方來源

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