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FDA 510(k)

J.E.T. DIALYSIS SYSTEM

K-Number: K820575 · 1982-05-20

ApplicantComputer Dialysis Systems, Inc.
Decision Date1982-05-20
Product CodeFKJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

J.E.T. DIALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Computer Dialysis Systems, Inc.. It received FDA 510(k) clearance on 1982-05-20 under 510(k) number K820575. The device is classified under product code FKJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J.E.T. DIALYSIS SYSTEM?

J.E.T. DIALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1982-05-20. The listed applicant is Computer Dialysis Systems, Inc.. The 510(k) number is K820575.

When did J.E.T. DIALYSIS SYSTEM receive FDA 510(k) clearance?

J.E.T. DIALYSIS SYSTEM received FDA 510(k) clearance on 1982-05-20, under 510(k) number K820575.

Who is the listed applicant for J.E.T. DIALYSIS SYSTEM?

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

What is the FDA product code for J.E.T. DIALYSIS SYSTEM?

The FDA product code for J.E.T. DIALYSIS SYSTEM is FKJ.

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 Computer Dialysis Systems, Inc. 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.

K850127FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 GK831132COMPUDIAL/KP-1K813107COMPUDIAL/KP-1

Related Devices (Code: FKJ)

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.

K253863GUARDIAN™ Quick Dip Residual Chlorine (5212)Serim ResearchK901734SERIM RESIDUAL CHLORINE TEST KITSerim Research Corp.K841307BBL GASPAK POUCHBd Becton Dickinson Vacutainer Systems PreanalyticK772040TRANSDUCER PROTECTORTerumo America, Inc.

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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