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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 K972470
Device Name CRIT-LINE MONITOR (CLMIII)
Applicant
In-Line Diagnostics Corp.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact THOMAS J BOUCHARD
Correspondent
In-Line Diagnostics Corp.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact THOMAS J BOUCHARD
Regulation Number876.5820
Classification Product Code
MQS  
Date Received07/01/1997
Decision Date 12/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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