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FDA 510(k)

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE

K-Number: K930181 · 1995-11-29

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

Device Summary

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE 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 K930181. 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 BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE?

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE 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 K930181.

When did BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE receive FDA 510(k) clearance?

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE received FDA 510(k) clearance on 1995-11-29, under 510(k) number K930181.

Who is the listed applicant for BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE?

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 BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE?

The FDA product code for BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE is 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.

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