FDA 510(k)

VPAP Adapt SV、VPAP Tx、S9 VPAP Tx

K 號：K161487 · 2016-09-09

決定日期2016-09-09

產品代碼MNS

諮詢委員會AN

決定相當於

器材摘要

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx 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 K161487. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx 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 K161487.

When did VPAP Adapt SV, VPAP Tx, S9 VPAP Tx receive FDA 510(k) clearance?

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161487.

Who is the listed applicant for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?

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 VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?

The FDA product code for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is MNS. This falls under the Neurology category.

其他以 Resmed, Ltd. 為申請人之記錄

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相關器械（代碼：MNS）

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。

K251889我的空氣Resmed Corp K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661瑪麗安娜·米涅瓦；瑪麗安娜·尼布斯Resmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical AB K231064ReddyPort 肘關節Smd Manufacturing, LLC K213169BPAP系統BMC Medical Co., Ltd.

官方來源

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