FDA 510(k)

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

K-Number: K955423 · 1996-06-13

Decision Date1996-06-13

Product CodeFKP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PACK H HEMODIALYSIS 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 1996-06-13 under 510(k) number K955423. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM?

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K955423.

When did PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM receive FDA 510(k) clearance?

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM received FDA 510(k) clearance on 1996-06-13, under 510(k) number K955423.

Who is the listed applicant for PACK H HEMODIALYSIS 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 PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM?

The FDA product code for PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM is FKP.

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Other records listing Fresenius USA, Inc. as applicant

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Related Devices (Code: FKP)

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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.