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FDA 510(k)

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

K-Number: K955762 · 1996-07-31

ApplicantFresenius USA, Inc.
Decision Date1996-07-31
Product CodeKPF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1996-07-31 under 510(k) number K955762. 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 PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM?

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM is a medical device that received FDA 510(k) clearance on 1996-07-31. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K955762.

When did PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM receive FDA 510(k) clearance?

PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM received FDA 510(k) clearance on 1996-07-31, under 510(k) number K955762.

Who is the listed applicant for PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM?

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

What is the FDA product code for PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM?

The FDA product code for PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM is KPF.

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Other records listing Fresenius USA, 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.

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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 CorpK970989CYBERRENCybernius Medical , Ltd.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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