FDA 510(k)

TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV

K-Number: K002816 · 2000-11-22

Decision Date2000-11-22

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV is the device name listed in this FDA 510(k) record. The listed applicant is Transonic Systems, Inc.. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K002816. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV?

TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Transonic Systems, Inc.. The 510(k) number is K002816.

When did TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV receive FDA 510(k) clearance?

TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV received FDA 510(k) clearance on 2000-11-22, under 510(k) number K002816.

Who is the listed applicant for TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV?

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

What is the FDA product code for TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV?

The FDA product code for TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV is KOC.

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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.