FDA 510(k)

F&P Nivairo RT047 通氣醫院全臉罩，防窒息閥版本

K 號：K191624 · 2020-03-09

決定日期2020-03-09

產品代碼MNT

諮詢委員會AN

決定相當於

器材摘要

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2020-03-09 under 510(k) number K191624. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K191624.

When did F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version receive FDA 510(k) clearance?

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version received FDA 510(k) clearance on 2020-03-09, under 510(k) number K191624.

Who is the listed applicant for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version?

The FDA product code for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version is MNT.

其他以 Fisher & Paykel Healthcare Limited 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。

K262268Optiflow 氧氣套件 (AA484J)K243583F&P 索瓦鼻罩 K233829諾瓦微枕口罩小號A型（NVP1SA）；諾瓦微枕口罩中號A型（NVP1MA）；諾瓦微枕口罩大號A型（NVP1LA）；諾瓦微枕口罩適配包/SML A型（NVP1SMLA）；諾瓦微枕口罩小號睡眠實驗室A型（NVP1SSLA）；諾瓦微枕口罩中號睡眠實驗室A型（NVP1MSLA）；諾瓦微枕口罩大號睡眠實驗室A型（NVP1LSLA）；諾瓦微枕口罩適配包睡眠實驗室A型（NVP1SMLSLA）K211560Airvo 蒸發器適配器 K173770OJR215 压力釋放集管 K173060F&P Nivairo™ RT046 非通氣醫院全臉罩，標準肘節版本

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相關器械（代碼：MNT）

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。

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官方來源

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