FDA 510(k)

iQ 2 鼻腔通氣口罩；幻影 2 鼻腔通氣口罩

K 號：K241469 · 2024-06-15

決定日期2024-06-15

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2024-06-15 under 510(k) number K241469. 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 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask?

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask is a medical device that received FDA 510(k) clearance on 2024-06-15. The listed applicant is Sleepnet Corporation. The 510(k) number is K241469.

When did iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask receive FDA 510(k) clearance?

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask received FDA 510(k) clearance on 2024-06-15, under 510(k) number K241469.

Who is the listed applicant for iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask?

The FDA 510(k) record lists Sleepnet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask?

The FDA product code for iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask is BZD.

其他以 Sleepnet Corporation 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。

K251847Sleepnet Arie 全面通氣口罩；Sleepnet Arie 鼻部通氣口罩 K241830Mojo 全面通風口罩；Veraseal 2 全面通風口罩；Innova 全面通風口罩；Ascend 全面通風口罩 K241943Mojo全臉不透氣口罩；Veraseal 2全臉不透氣口罩；Veraseal 2全臉AAV不透氣口罩 K241661Mojo 2 全面通風口罩；Veraseal 3 全面通風口罩；V3 全面通風口罩 K241520Mojo 2 全面非通氣口罩；Mojo 2 全面 AAV 非通氣口罩；Veraseal 3 全面非通氣口罩；Veraseal 3 全面 AAV 非通氣口罩 K211274iQ 2 鼻罩，幻影 2 鼻罩

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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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