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FDA 510(k)

BAXTER BIOSTAT 1000 UREA MONITOR

K-Number: K925581 · 1995-05-03

ApplicantBaxter Healthcare Corp
Decision Date1995-05-03
Product CodeKXM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAXTER BIOSTAT 1000 UREA MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K925581. The device is classified under product code KXM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER BIOSTAT 1000 UREA MONITOR?

BAXTER BIOSTAT 1000 UREA MONITOR is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K925581.

When did BAXTER BIOSTAT 1000 UREA MONITOR receive FDA 510(k) clearance?

BAXTER BIOSTAT 1000 UREA MONITOR received FDA 510(k) clearance on 1995-05-03, under 510(k) number K925581.

Who is the listed applicant for BAXTER BIOSTAT 1000 UREA MONITOR?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAXTER BIOSTAT 1000 UREA MONITOR?

The FDA product code for BAXTER BIOSTAT 1000 UREA MONITOR is KXM.

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Related Devices (Code: KXM)

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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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