FDA 510(k)

Mojo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

K 號：K241943 · 2024-08-28

決定日期2024-08-28

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-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 2024-08-28 under 510(k) number K241943. 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 Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask?

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Sleepnet Corporation. The 510(k) number is K241943.

When did Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask receive FDA 510(k) clearance?

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask received FDA 510(k) clearance on 2024-08-28, under 510(k) number K241943.

Who is the listed applicant for Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-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 Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask?

The FDA product code for Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask is CBK.

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 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 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：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

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