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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 K821823
Device Name I.V. SENTINEL
Applicant
The John Bunn Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The John Bunn Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2420
Classification Product Code
FLN  
Date Received06/22/1982
Decision Date 08/16/1982
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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