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FDA 510(k)

COMPUDIAL/KP-1

K-Number: K813107 · 1982-03-23

ApplicantComputer Dialysis Systems, Inc.
Decision Date1982-03-23
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMPUDIAL/KP-1 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 1982-03-23 under 510(k) number K813107. 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 COMPUDIAL/KP-1?

COMPUDIAL/KP-1 is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Computer Dialysis Systems, Inc.. The 510(k) number is K813107.

When did COMPUDIAL/KP-1 receive FDA 510(k) clearance?

COMPUDIAL/KP-1 received FDA 510(k) clearance on 1982-03-23, under 510(k) number K813107.

Who is the listed applicant for COMPUDIAL/KP-1?

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 COMPUDIAL/KP-1?

The FDA product code for COMPUDIAL/KP-1 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 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-1K820575J.E.T. DIALYSIS 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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