CRIT-LINE MONITOR III TQA (CLM TQA)— 510(k) K011741

Name: FDA 510(k) clearance K011741
Creator: U.S. Food and Drug Administration
Published: 2002-07-23

Substantially Equivalent

Hemametrics

FDA 510(k) clearance K011741 for CRIT-LINE MONITOR III TQA (CLM TQA), Substantially Equivalent on 2002-07-23. Applicant: Hemametrics. Device class: 2.

Clearance details

Applicant: Hemametrics
Product code: Code FIL
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-05
Decision date: 2002-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaysville, UT, US

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