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FDA 510(k)

Nivairo RT045 非通氣醫院全臉罩防窒息閥 - 大號，Nivairo RT045 非通氣醫院全臉罩防窒息閥 - 中號，Nivairo RT045 非通氣醫院全臉罩防窒息閥 - 小號，Nivairo RT045 非通氣醫院全臉罩防窒息閥 - 超小號

K 號：K170367 · 2017-08-24

申請人Fisher and Paykel Healthcare Limited
決定日期2017-08-24
產品代碼MNT
諮詢委員會AN
決定相當於

器材摘要

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small is the device name listed in this FDA 510(k) record. The listed applicant is Fisher and Paykel Healthcare Limited. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K170367. 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 Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small?

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Fisher and Paykel Healthcare Limited. The 510(k) number is K170367.

When did Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small receive FDA 510(k) clearance?

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small received FDA 510(k) clearance on 2017-08-24, under 510(k) number K170367.

Who is the listed applicant for Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small?

FDA 510(k) 記錄中將 Fisher and Paykel Healthcare Limited 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small?

The FDA product code for Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small is MNT.

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其他以 Fisher and 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K191624F&P Nivairo RT047 通氣醫院全臉罩，防窒息閥版本K173770OJR215 压力釋放集管

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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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