FDA 510(k)

SleepWeaver 先進兒童鼻罩 CPAP Mask

K 號：K151683 · 2016-04-05

決定日期2016-04-05

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

SleepWeaver Advance Pediatric Nasal CPAP Mask is the device name listed in this FDA 510(k) record. The listed applicant is Circadiance, LLC. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K151683. 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 SleepWeaver Advance Pediatric Nasal CPAP Mask?

SleepWeaver Advance Pediatric Nasal CPAP Mask is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Circadiance, LLC. The 510(k) number is K151683.

When did SleepWeaver Advance Pediatric Nasal CPAP Mask receive FDA 510(k) clearance?

SleepWeaver Advance Pediatric Nasal CPAP Mask received FDA 510(k) clearance on 2016-04-05, under 510(k) number K151683.

Who is the listed applicant for SleepWeaver Advance Pediatric Nasal CPAP Mask?

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

What is the FDA product code for SleepWeaver Advance Pediatric Nasal CPAP Mask?

The FDA product code for SleepWeaver Advance Pediatric Nasal CPAP Mask is BZD.

其他以 Circadiance, LLC 為申請人之記錄

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K162905SleepWeaver 3D 鼻罩

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。

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官方來源

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