FDA 510(k)

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

K 號：K160822 · 2016-09-09

決定日期2016-09-09

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160822. 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 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV?

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Resmed, Ltd.. The 510(k) number is K160822.

When did S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV receive FDA 510(k) clearance?

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160822.

Who is the listed applicant for S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV?

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

What is the FDA product code for S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV?

The FDA product code for S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV is BZD.

其他以 Resmed, Ltd. 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。

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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。

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