FDA 510(k)

Spectrum-2

K 號：K254129 · 2026-05-22

決定日期2026-05-22

產品代碼MUD

諮詢委員會履歷

決定相當於

器材摘要

Spectrum-2 is the device name listed in this FDA 510(k) record. The listed applicant is Neko Health AB. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K254129. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spectrum-2?

Spectrum-2 is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Neko Health AB. The 510(k) number is K254129.

When did Spectrum-2 receive FDA 510(k) clearance?

Spectrum-2 received FDA 510(k) clearance on 2026-05-22, under 510(k) number K254129.

Who is the listed applicant for Spectrum-2?

FDA 510(k) 記錄將 Neko Health AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Spectrum-2?

The FDA product code for Spectrum-2 is MUD.

其他以 Neko Health AB 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。

K254240回聲-2 K253911德瑪-2

相關器械（代碼：MUD）

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。

K243324馬斯米O3地區性血氧儀Masimo Corporation K250519Lap.Ox™ 鍋鏡組織氧濃度計ViOptix, Inc.K240596大腦自調節指數（CAI）算法Edwards Lifesciences K241393ODI-TechOdi Medical AS K240601快照NIR型 KD205Kent Imaging, Inc.K232385OxiplexTS200Iss Medical, Inc.

官方來源

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