FDA 510(k)

Maxtec 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

K 號：K221734 · 2023-04-01

決定日期2023-04-01

產品代碼CCL

諮詢委員會AN

決定相當於

器材摘要

Maxtec MaxO2 ME+p is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2023-04-01 under 510(k) number K221734. 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 Maxtec MaxO2 ME+p?

Maxtec MaxO2 ME+p is a medical device that received FDA 510(k) clearance on 2023-04-01. The listed applicant is Maxtec, LLC. The 510(k) number is K221734.

When did Maxtec MaxO2 ME+p receive FDA 510(k) clearance?

Maxtec MaxO2 ME+p received FDA 510(k) clearance on 2023-04-01, under 510(k) number K221734.

Who is the listed applicant for Maxtec MaxO2 ME+p?

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

What is the FDA product code for Maxtec MaxO2 ME+p?

The FDA product code for Maxtec MaxO2 ME+p is CCL.

其他以 Maxtec, LLC 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。

K231895Maxtec MaxBlend2+p 医療設備規範文本翻譯： Maxtec MaxBlend2+p 医療設備規範文本 K182362MaxCap 優兒系列及 MaxCap Neo K161718MaxBlend 2, MaxBlend Lite K153659MaxO2ME

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 K213933氧氣濃度感測器Careox, LLC K213948氧氣監控器Bio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。