FDA 510(k)

Mojo 2 全面通風口罩；Veraseal 3 全面通風口罩；V3 全面通風口罩

K 號：K241661 · 2024-07-10

決定日期2024-07-10

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face 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 2024-07-10 under 510(k) number K241661. 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 Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask?

Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Sleepnet Corporation. The 510(k) number is K241661.

When did Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask receive FDA 510(k) clearance?

Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask received FDA 510(k) clearance on 2024-07-10, under 510(k) number K241661.

Who is the listed applicant for Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face 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 Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask?

The FDA product code for Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face 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 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 K241469iQ 2 鼻腔通氣口罩；幻影 2 鼻腔通氣口罩 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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