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FDA 510(k)

DIALYZER REPROCESSING SYSTEM

K-Number: K944492 · 1995-08-28

ApplicantG.E.M. Water Systems
Decision Date1995-08-28
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYZER REPROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is G.E.M. Water Systems. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K944492. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYZER REPROCESSING SYSTEM?

DIALYZER REPROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is G.E.M. Water Systems. The 510(k) number is K944492.

When did DIALYZER REPROCESSING SYSTEM receive FDA 510(k) clearance?

DIALYZER REPROCESSING SYSTEM received FDA 510(k) clearance on 1995-08-28, under 510(k) number K944492.

Who is the listed applicant for DIALYZER REPROCESSING SYSTEM?

The FDA 510(k) record lists G.E.M. Water Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIALYZER REPROCESSING SYSTEM?

The FDA product code for DIALYZER REPROCESSING SYSTEM is LIF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing G.E.M. Water Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970674G.E.M. WATER SYSTEMS, INTERNATIONALK944493REVERSE OSMOSIS SYSTEM

Related Devices (Code: LIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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