FDA 510(k)

步行氧行者

K 號：K161472 · 2016-11-18

決定日期2016-11-18

產品代碼ECX

諮詢委員會AN

決定相當於

器材摘要

Walk-O2-Bout is the device name listed in this FDA 510(k) record. The listed applicant is Essex Industries, Inc.. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K161472. The device is classified under product code ECX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Walk-O2-Bout?

Walk-O2-Bout is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Essex Industries, Inc.. The 510(k) number is K161472.

When did Walk-O2-Bout receive FDA 510(k) clearance?

Walk-O2-Bout received FDA 510(k) clearance on 2016-11-18, under 510(k) number K161472.

Who is the listed applicant for Walk-O2-Bout?

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

What is the FDA product code for Walk-O2-Bout?

The FDA product code for Walk-O2-Bout is ECX.

其他以 Essex Industries, 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。

K162811MR條件CGA 870

相關器械（代碼：ECX）

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。

K161179Intelli-OxAir Liquide Healthcare America Corporation K153518Medipure 氧氣-LC 系統Praxair Distribution, Incorporated.

官方來源

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