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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K013709
Device Name HILL-ROM PRIMAVIEW MONITOR SYSTEM
Applicant
HILL-ROM, INC.
1069 STATE RT. 46 EAST
BATESVILLE,  IN  47006
Applicant Contact TIMOTHY M DAVIS
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number876.1500
Classification Product Code
FET  
Date Received11/08/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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