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FDA 510(k)

智能檢查O2 (MA0236)

K 號：K250002 · 2025-04-24

申請人Life Spark Medical, LLC
決定日期2025-04-24
產品代碼CCL
諮詢委員會AN
決定相當於

器材摘要

Smart Check O2 (MA0236) is the device name listed in this FDA 510(k) record. The listed applicant is Life Spark Medical, LLC. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250002. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smart Check O2 (MA0236)?

Smart Check O2 (MA0236) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Life Spark Medical, LLC. The 510(k) number is K250002.

When did Smart Check O2 (MA0236) receive FDA 510(k) clearance?

Smart Check O2 (MA0236) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250002.

Who is the listed applicant for Smart Check O2 (MA0236)?

The FDA 510(k) record lists Life Spark Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Check O2 (MA0236)?

The FDA product code for Smart Check O2 (MA0236) is CCL.

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

相關器械（代碼：CCL）

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。

K261389PRO2 Elite Plus 氧氣分析儀 (PRO2PLUS-1)Salter LabsK251245氧氣監控器 Pro (10310)Bio-Med Device, Inc.K221734Maxtec MaxO2 ME+p 医療設備規範文本翻譯： Maxtec MaxO2 ME+p 医療設備規範文本Maxtec, LLCK213933氧氣濃度感測器Careox, LLCK213948氧氣監控器Bio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

官方來源

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