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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K090610
Device Name HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
D-389, BLDG., H2
LAKE FOREST,  IL  60045
Applicant Contact Yuliya Matlin
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number870.2910
Classification Product Code
DRG  
Date Received03/06/2009
Decision Date 03/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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