CRIT-LINE MONITOR (CLMIII)— 510(k) K972470

Name: FDA 510(k) clearance K972470
Creator: U.S. Food and Drug Administration
Published: 1997-12-11

Substantially Equivalent

In-Line Diagnostics Corp.

FDA 510(k) clearance K972470 for CRIT-LINE MONITOR (CLMIII), Substantially Equivalent on 1997-12-11. 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: 1997-07-01
Decision date: 1997-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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