FDA 510(k)

Intra.Ox™ 2.0 手持組織血氧計

K 號：K233488 · 2024-02-28

決定日期2024-02-28

產品代碼MUD

諮詢委員會履歷

決定相當於

器材摘要

Intra.Ox™ 2.0 Handheld Tissue Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Vioptix, Inc.. It received FDA 510(k) clearance on 2024-02-28 under 510(k) number K233488. 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 Intra.Ox™ 2.0 Handheld Tissue Oximeter?

Intra.Ox™ 2.0 Handheld Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2024-02-28. The listed applicant is Vioptix, Inc.. The 510(k) number is K233488.

When did Intra.Ox™ 2.0 Handheld Tissue Oximeter receive FDA 510(k) clearance?

Intra.Ox™ 2.0 Handheld Tissue Oximeter received FDA 510(k) clearance on 2024-02-28, under 510(k) number K233488.

Who is the listed applicant for Intra.Ox™ 2.0 Handheld Tissue Oximeter?

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

What is the FDA product code for Intra.Ox™ 2.0 Handheld Tissue Oximeter?

The FDA product code for Intra.Ox™ 2.0 Handheld Tissue Oximeter is MUD.

其他以 Vioptix, 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。

K250519Lap.Ox™ 鍋鏡組織氧濃度計 K221010Intra.Ox 2.0 手持組織血氧計 K191676Intra.Ox 2.0 手持組織血氧計 K163472Intra.Ox 雙手持式組織血氧計

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。

K254129Spectrum-2Neko Health AB 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.

官方來源

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