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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemodialysis, Access Recirculation Monitoring
510(k) Number K992227
Device Name CRIT-LINE MONITOR III (CLM III)
Applicant
In-Line Diagnostics Corp.
117 W. 200 S.
Farmington,  UT  84025
Applicant Contact MATTHEW L HAYNIE
Correspondent
In-Line Diagnostics Corp.
117 W. 200 S.
Farmington,  UT  84025
Correspondent Contact MATTHEW L HAYNIE
Regulation Number876.5820
Classification Product Code
MQS  
Date Received07/02/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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