FDA 510(k)

TRIEX-IH DIALYZER

K-Number: K822738 · 1982-09-24

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1982-09-24

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TRIEX-IH DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1982-09-24 under 510(k) number K822738. 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 TRIEX-IH DIALYZER?

TRIEX-IH DIALYZER is a medical device that received FDA 510(k) clearance on 1982-09-24. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K822738.

When did TRIEX-IH DIALYZER receive FDA 510(k) clearance?

TRIEX-IH DIALYZER received FDA 510(k) clearance on 1982-09-24, under 510(k) number K822738.

Who is the listed applicant for TRIEX-IH DIALYZER?

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

What is the FDA product code for TRIEX-IH DIALYZER?

The FDA product code for TRIEX-IH DIALYZER is KOC.

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Official Source

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