FDA 510(k)

簡易T兒童鼻罩

K 號：K151120 · 2016-04-15

決定日期2016-04-15

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

Simple T Pediatric Nasal Mask is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K151120. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Simple T Pediatric Nasal Mask?

Simple T Pediatric Nasal Mask is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Respironics, Inc.. The 510(k) number is K151120.

When did Simple T Pediatric Nasal Mask receive FDA 510(k) clearance?

Simple T Pediatric Nasal Mask received FDA 510(k) clearance on 2016-04-15, under 510(k) number K151120.

Who is the listed applicant for Simple T Pediatric Nasal Mask?

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 Simple T Pediatric Nasal Mask?

The FDA product code for Simple T Pediatric Nasal Mask is BZD.

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。

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相關器械（代碼：BZD）

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Respironics, Inc.K253044RXiBreeze PAP系統（RXiBreeze 20C）Resvent Medical Technology Co., Ltd.K253553歐里安Resmed Corp K254104ResScan 基礎版Resmed Corp K251920睡眠呼吸中止症呼吸治療面罩：JoyMask 20-B 全面罩，JoyMask 21-B 全面罩Dcstar, Inc.K253166F6S 全面罩 (F6S)；P6S 鼻枕接口 (P6S)BMC Medical Co., Ltd.

官方來源

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