FDA 510(k)

HydraGuard 10 超濾器

K 號：K161467 · 2016-12-22

決定日期2016-12-22

產品代碼NHV

諮詢委員會GU

決定相當於

器材摘要

HydraGuard 10 UltraFilter is the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K161467. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HydraGuard 10 UltraFilter?

HydraGuard 10 UltraFilter is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Nephros, Inc.. The 510(k) number is K161467.

When did HydraGuard 10 UltraFilter receive FDA 510(k) clearance?

HydraGuard 10 UltraFilter received FDA 510(k) clearance on 2016-12-22, under 510(k) number K161467.

Who is the listed applicant for HydraGuard 10 UltraFilter?

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

What is the FDA product code for HydraGuard 10 UltraFilter?

The FDA product code for HydraGuard 10 UltraFilter is NHV.

其他以 Nephros, Inc. 為申請人之記錄

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相關器械（代碼：NHV）

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