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FDA 510(k)

Optiflow+ 鼻管 - 小型 (OPT942)；Optiflow+ 鼻管 - 中型 (OPT944)；Optiflow+ 鼻管 - 大型 (OPT946)；Optiflow+ 鼻管 小型 (MYOPT9SMALL)；Optiflow+ 鼻管 中型 (MYOPT9MEDIUM)；Optiflow+ 鼻管 大型 (MYOPT9LARGE)

K 號：K251611 · 2025-06-25

申請人Fisher & Paykel Healthcare, Ltd.
決定日期2025-06-25
產品代碼BTT
諮詢委員會AN
決定相當於

器材摘要

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K251611. 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 Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K251611.

When did Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) receive FDA 510(k) clearance?

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K251611.

Who is the listed applicant for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

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

What is the FDA product code for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

The FDA product code for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is BTT.

相關臨床試驗

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其他以 Fisher & Paykel Healthcare, Ltd. 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。

K253479Optiflow Switch+ 過濾鼻接口配二氧化碳採樣功能 (AA042J)K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS)；OptiPAP Junior 鼻管 XXS (OPTIPAPPXXS)；OptiPAP Junior 鼻管 XS (OPTIPAPPXS)；OptiPAP Junior 鼻管 S (OPTIPAPPS)；OptiPAP Junior 鼻管 M (OPTIPAPPM)；OptiPAP Junior 鼻管 L (OPTIPAPPL)；OptiPAP Junior 鼻管 XL (OPTIPAPPXL)；OptiPAP Junior 鼻罩 XXS (OPTIPAPMXXS)；OptiPAP Junior 鼻罩 XS (OPTIPAPMXS)；OptiPAP Junior 鼻罩 S (OPTIPAPMS)；OptiPAP Junior 鼻罩 M (OPTIPAPMM)；OptiPAP JuniorK252173F&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K243917F&P Optiflow 氧氣/空氣流量來源K234053F&P Optiflow 樹狀分流器K233643F&P Airvo 3 NIV (PT311US)

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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 LimitedK254078HVT 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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