FDA 510(k)

AMICON EQUALINE FLUID BALANCE SYSTEM

K-Number: K875121 · 1988-02-19

Decision Date1988-02-19

Product CodeKPF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AMICON EQUALINE FLUID BALANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amicon, Inc.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K875121. The device is classified under product code KPF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICON EQUALINE FLUID BALANCE SYSTEM?

AMICON EQUALINE FLUID BALANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Amicon, Inc.. The 510(k) number is K875121.

When did AMICON EQUALINE FLUID BALANCE SYSTEM receive FDA 510(k) clearance?

AMICON EQUALINE FLUID BALANCE SYSTEM received FDA 510(k) clearance on 1988-02-19, under 510(k) number K875121.

Who is the listed applicant for AMICON EQUALINE FLUID BALANCE SYSTEM?

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

What is the FDA product code for AMICON EQUALINE FLUID BALANCE SYSTEM?

The FDA product code for AMICON EQUALINE FLUID BALANCE SYSTEM is KPF.

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Other records listing Amicon, Inc. as applicant

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Related Devices (Code: KPF)

K061515RENALSOFTBaxter Healthcare Corp K990953RENAL LINKBaxter Healthcare Corp K970989CYBERRENCybernius Medical , Ltd.K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.K913515TOTAL CONTAINMENT DEVICEDenco K874020ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICEAbbott Laboratories

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.