BAXTER BIOSTAT 1000 UREA MONITOR— 510(k) K925581

Name: FDA 510(k) clearance K925581
Creator: U.S. Food and Drug Administration
Published: 1995-05-03

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K925581 for BAXTER BIOSTAT 1000 UREA MONITOR, Substantially Equivalent on 1995-05-03. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KXM
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1992-11-05
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

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