FDA 510(k)

三麗宮Evo

K 號：K181166 · 2019-07-18

決定日期2019-07-18

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

Trilogy Evo is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K181166. 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 Trilogy Evo?

Trilogy Evo is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Respironics, Inc.. The 510(k) number is K181166.

When did Trilogy Evo receive FDA 510(k) clearance?

Trilogy Evo received FDA 510(k) clearance on 2019-07-18, under 510(k) number K181166.

Who is the listed applicant for Trilogy Evo?

FDA 510(k) 記錄將Respironics, Inc.列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Trilogy Evo?

The FDA product code for Trilogy Evo is CBK.

其他以 Respironics, 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。

K261262Altis 全面罩 K243394AF531 鼻咽腔SE面罩 K231313治療面罩 3100 NC/SP K210844夢幻穿戴矽膠枕型口罩 K210386磁力鼻罩 K202142睡眠裝置 G3

查看所有 16 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。