FDA 510(k)

舒適流濕化系統

K 號：K162242 · 2017-01-19

決定日期2017-01-19

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

Comfort Flo Humidification System is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K162242. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Comfort Flo Humidification System?

Comfort Flo Humidification System is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162242.

When did Comfort Flo Humidification System receive FDA 510(k) clearance?

Comfort Flo Humidification System received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162242.

Who is the listed applicant for Comfort Flo Humidification System?

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

What is the FDA product code for Comfort Flo Humidification System?

The FDA product code for Comfort Flo Humidification System is BTT.

其他以 Teleflexmedical, 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。

K232469魯施天然乳膠金屬福樸導尿管 K212077泰勒弗萊克斯魯斯柔簡塑福利歐導尿管 K192324雪倫螺旋柔軟氣管內管 K182847Hudson RCI Voldyne體積訓練器 K181979魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管 K183461魯士Flocath親水性間歇性導尿管，魯士MMG親水性間歇性導尿管

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相關器械（代碼：BTT）

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。

K262268Optiflow 氧氣套件 (AA484J)Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U 呼吸濕化器Flexicare Medical Limited.K251419生物加倫尼克實驗室靜脈注射用无菌水，USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ 過濾鼻接口配二氧化碳採樣功能 (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® 舒適流鼻管預產期、嬰兒；Hudson RCI® 舒適流 Plus 及軟 Plus 鼻管超小號Medline Industries, LP

官方來源

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