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FDA 510(k)

ULTRA 1040

K 號：K241996 · 2025-04-18

申請人Ecoray Co., Ltd.
決定日期2025-04-18
產品代碼IZL
諮詢委員會RA
決定相當於

器材摘要

ULTRA 1040 is the device name listed in this FDA 510(k) record. The listed applicant is Ecoray Co., Ltd.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K241996. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ULTRA 1040?

ULTRA 1040 is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Ecoray Co., Ltd.. The 510(k) number is K241996.

When did ULTRA 1040 receive FDA 510(k) clearance?

ULTRA 1040 received FDA 510(k) clearance on 2025-04-18, under 510(k) number K241996.

Who is the listed applicant for ULTRA 1040?

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

What is the FDA product code for ULTRA 1040?

The FDA product code for ULTRA 1040 is IZL.

相關臨床試驗

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：IZL）

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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