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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K133870
Device Name FLUID LEVEL MONITOR
Applicant
Coleman Laboratories
1150 First Ave., Suite 501
King Of Prussia,  PA  19406
Applicant Contact LE-JUN YIN
Correspondent
Coleman Laboratories
1150 First Ave., Suite 501
King Of Prussia,  PA  19406
Correspondent Contact LE-JUN YIN
Regulation Number880.2420
Classification Product Code
FLN  
Date Received12/20/2013
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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