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FDA 510(k)

Unimed 可重用手指夾式SpO2感測器 (U103-125)；Unimed 可重用手指夾式SpO2感測器 (U403-254)；Unimed 可重用手指夾式SpO2感測器 (U103-254)；Unimed 可重用手指夾式SpO2感測器 (U403-125)

K 號：K242580 · 2025-02-06

申請人Unimed Medical Supplies, Inc.
決定日期2025-02-06
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) is the device name listed in this FDA 510(k) record. The listed applicant is Unimed Medical Supplies, Inc.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K242580. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)?

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Unimed Medical Supplies, Inc.. The 510(k) number is K242580.

When did Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) receive FDA 510(k) clearance?

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) received FDA 510(k) clearance on 2025-02-06, under 510(k) number K242580.

Who is the listed applicant for Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)?

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

What is the FDA product code for Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)?

The FDA product code for Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) is DQA.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Unimed Medical Supplies, 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。

K253162溫度探針（T2252-PG）；溫度探針（TCMA-AG）；溫度探針（TCMA-PG）；溫度探針（TMQ-DAG）；溫度探針（THP-DAG）K260931Unimed可重用手指夾式SpO2感測器（U403-49R及U103-49R）K253964可抛弃式新生兒NIBP袖帶 (U1681S-C51N)K251691Unimed 可重用SpO2感測器（-08系列）（U403S-08）；Unimed 可重用SpO2感測器（-08系列）（U203S-08）；Unimed 可重用SpO2感測器（-08系列）（U103S-08）；Unimed 可重用SpO2感測器（-08系列）（U103-08）K251696Unimed可重用SpO2感測器（-48系列及-29系列）（U410-48）；Unimed可重用SpO2感測器（-48系列及-29系列）（U410-29）K251695Unimed可重用SpO2感測器（-06系列）（U403S-06）；Unimed可重用SpO2感測器（-06系列）（U203S-06）；Unimed可重用SpO2感測器（-06系列）（U103S-06）

查看所有 13 項裝置 →

相關器械（代碼：DQA）

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。

K252821可重用成人SpO2夾式感測器（3m）（M1196A）；可重用成人SpO2夾式感測器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbHK252655心脈血氧濃度計（PO-A2AO、PO-A2AT、PO-A3AO、PO-H1AO、PO-B1AO、PO-C5AO、PO-C5AT、PO-C6AO、PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2感測器（989803205381）；鼻翼SpO2感測器（989803205391）；鼻翼Sp02感測器（989803205401）Philips Medizin SystemeK260931Unimed可重用手指夾式SpO2感測器（U403-49R及U103-49R）Unimed Medical Supplies, Inc.K252448AViTA脉搏血氧儀 (SP61)Avita CorporationK252805YUWELL®手指血氧計（YX105、YX106、YX110、YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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