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FDA 510(k)

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER

K-Number: K110285 · 2011-07-14

ApplicantNephros, Inc.
Decision Date2011-07-14
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2011-07-14 under 510(k) number K110285. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER?

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER is a medical device that received FDA 510(k) clearance on 2011-07-14. The listed applicant is Nephros, Inc.. The 510(k) number is K110285.

When did NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER receive FDA 510(k) clearance?

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER received FDA 510(k) clearance on 2011-07-14, under 510(k) number K110285.

Who is the listed applicant for NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER?

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 DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER?

The FDA product code for NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER is FIP.

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Other records listing Nephros, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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