FDA 510(k)

氧氣監控器

K 號：K213948 · 2022-03-17

決定日期2022-03-17

產品代碼CCL

諮詢委員會AN

決定相當於

器材摘要

OxyMinder is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 2022-03-17 under 510(k) number K213948. 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 OxyMinder?

OxyMinder is a medical device that received FDA 510(k) clearance on 2022-03-17. The listed applicant is Bio-Med Devices, Inc.. The 510(k) number is K213948.

When did OxyMinder receive FDA 510(k) clearance?

OxyMinder received FDA 510(k) clearance on 2022-03-17, under 510(k) number K213948.

Who is the listed applicant for OxyMinder?

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

What is the FDA product code for OxyMinder?

The FDA product code for OxyMinder is CCL.

其他以 Bio-Med Devices, Inc. 為申請人之記錄

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K173973TV-100

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 Labs K251245氧氣監控器 Pro (10310)Bio-Med Device, Inc.K250002智能檢查O2 (MA0236)Life Spark Medical, LLC 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, LLC K213933氧氣濃度感測器Careox, LLC K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

官方來源

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