FDA 510(k)

Luna CPAP 及自動CPAP系統

K 號：K153387 · 2016-09-08

決定日期2016-09-08

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

Luna CPAP and Auto CPAP System is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K153387. 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 Luna CPAP and Auto CPAP System?

Luna CPAP and Auto CPAP System is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is 3B Medical, Inc.. The 510(k) number is K153387.

When did Luna CPAP and Auto CPAP System receive FDA 510(k) clearance?

Luna CPAP and Auto CPAP System received FDA 510(k) clearance on 2016-09-08, under 510(k) number K153387.

Who is the listed applicant for Luna CPAP and Auto CPAP System?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luna CPAP and Auto CPAP System?

The FDA product code for Luna CPAP and Auto CPAP System is BZD.

其他以 3B Medical, Inc. 為申請人之記錄

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K212263Luna G3 BPAP系統 K201620Luna® G3 BPAP 25A K200496Aer X K160127iCodeConnect

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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