FDA 510(k)

F&P Nivairo™ RT046 非通氣醫院全臉罩，標準肘節版本

K 號：K173060 · 2018-01-25

決定日期2018-01-25

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version 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 2018-01-25 under 510(k) number K173060. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Fisher and Paykel Healthcare Limited. The 510(k) number is K173060.

When did F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version receive FDA 510(k) clearance?

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version received FDA 510(k) clearance on 2018-01-25, under 510(k) number K173060.

Who is the listed applicant for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

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 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version?

The FDA product code for F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version is CBK.

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：CBK）

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。

K253647Evita (V800)；Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus 多功能Iconic Solutions by Murcia, SL K251888VPAP兒童臉部口罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸A (ONIV117A)；F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸B (ONIV117B)；F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F醫院通氣全臉罩，可選配呼氣過濾器，適用單肢循環 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F醫院通氣全臉罩Fisher & Paykel Healthcare, Ltd.K243767SV600、SV800 呼吸器Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方來源

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