FDA 510(k)

Chromix

K 號：K261473 · 2026-07-01

決定日期2026-07-01

產品代碼OHS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Chromix is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud S.L.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K261473. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Chromix?

Chromix is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Termosalud S.L.. The 510(k) number is K261473.

When did Chromix receive FDA 510(k) clearance?

Chromix received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261473.

Who is the listed applicant for Chromix?

The FDA 510(k) record lists Termosalud S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chromix?

The FDA product code for Chromix is OHS.

其他以 Termosalud S.L. 為申請人之記錄

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相關器械（代碼：OHS）

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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