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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 K831596
Device Name DROP RATE COUNTER #340
Applicant
Imed Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Imed Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2420
Classification Product Code
FLN  
Date Received05/17/1983
Decision Date 07/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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