FDA 510(k)

Nephros S100

K号: K153084 · 2016-04-08

决定日期2016-04-08

产品代码NHV

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决定实质等同

器械摘要

Nephros S100 is the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153084. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nephros S100?

Nephros S100 is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Nephros, Inc.. The 510(k) number is K153084.

When did Nephros S100 receive FDA 510(k) clearance?

Nephros S100 received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153084.

Who is the listed applicant for Nephros S100?

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 Nephros S100?

The FDA product code for Nephros S100 is NHV.

列明Nephros, Inc.为申报人的其他记录

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