Cleared Special

CRIT-LINE MONITOR III (CLM III)

K992227 · In-Line Diagnostics Corp. · Gastroenterology & Urology
Jul 1999
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K992227 is an FDA 510(k) clearance for the CRIT-LINE MONITOR III (CLM III), a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by In-Line Diagnostics Corp. (Farmington, US). The FDA issued a Cleared decision on July 30, 1999, 28 days after receiving the submission on July 2, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K992227 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1999
Decision Date July 30, 1999
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MQS — System, Hemodialysis, Access Recirculation Monitoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820