免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Mojo 2 全面非通氣口罩，Mojo 2 AAV 非通氣全面口罩，Veraseal 3 全面非通氣口罩，Veraseal 3 全面 AAV 非通氣

K 號：K190533 · 2019-07-26

申請人Sleepnet Corporation
決定日期2019-07-26
產品代碼CBK
諮詢委員會AN
決定相當於

器材摘要

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190533. 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 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented?

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Sleepnet Corporation. The 510(k) number is K190533.

When did Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented receive FDA 510(k) clearance?

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190533.

Who is the listed applicant for Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented?

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 Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented?

The FDA product code for Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented is CBK.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K241469iQ 2 鼻腔通氣口罩；幻影 2 鼻腔通氣口罩

查看所有 10 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 KgaaK252663Inbentus 多功能Iconic Solutions by Murcia, SLK251888VPAP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。

↑