CRIT-LINE MONITOR III (CLM III)— 510(k) K001763

Name: FDA 510(k) clearance K001763
Creator: U.S. Food and Drug Administration
Published: 2000-12-20

Substantially Equivalent

In-Line Diagnostics Corp.

FDA 510(k) clearance K001763 for CRIT-LINE MONITOR III (CLM III), Substantially Equivalent on 2000-12-20. Applicant: In-Line Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: In-Line Diagnostics Corp.
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2000-06-12
Decision date: 2000-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaysville, UT, US

Download summary PDF View on FDA.gov ↗

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