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FDA 510(k)

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER

K-Number: K944767 · 1995-11-29

ApplicantFresenius USA, Inc.
Decision Date1995-11-29
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER 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 1995-11-29 under 510(k) number K944767. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER?

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K944767.

When did DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER receive FDA 510(k) clearance?

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER received FDA 510(k) clearance on 1995-11-29, under 510(k) number K944767.

Who is the listed applicant for DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER?

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 DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER?

The FDA product code for DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER is FIP.

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Related Devices (Code: FIP)

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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.

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