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FDA 510(k)

CYBERREN

K-Number: K970989 · 1997-07-24

ApplicantCybernius Medical , Ltd.
Decision Date1997-07-24
Product CodeKPF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYBERREN is the device name listed in this FDA 510(k) record. The listed applicant is Cybernius Medical , Ltd.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K970989. 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 CYBERREN?

CYBERREN is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Cybernius Medical , Ltd.. The 510(k) number is K970989.

When did CYBERREN receive FDA 510(k) clearance?

CYBERREN received FDA 510(k) clearance on 1997-07-24, under 510(k) number K970989.

Who is the listed applicant for CYBERREN?

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

What is the FDA product code for CYBERREN?

The FDA product code for CYBERREN is KPF.

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Related Devices (Code: KPF)

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.

K061515RENALSOFTBaxter Healthcare CorpK990953RENAL LINKBaxter Healthcare CorpK955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.K913515TOTAL CONTAINMENT DEVICEDencoK875121AMICON EQUALINE FLUID BALANCE SYSTEMAmicon, Inc.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.

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