朱諾 VPAP ST-A
K 號：K153061 · 2016-04-13
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器材摘要
Juno VPAP ST-A is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K153061. 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 Juno VPAP ST-A?
Juno VPAP ST-A is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Resmed, Ltd.. The 510(k) number is K153061.
When did Juno VPAP ST-A receive FDA 510(k) clearance?
Juno VPAP ST-A received FDA 510(k) clearance on 2016-04-13, under 510(k) number K153061.
Who is the listed applicant for Juno VPAP ST-A?
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 Juno VPAP ST-A?
The FDA product code for Juno VPAP ST-A 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。
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。
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