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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 K103276
Device Name INTEL HEALTH GUIDE
Applicant
Intel Corporation Digital Health Group
1900 Prairie City Rd.
Fm7-197
Folsom,  CA  95630
Applicant Contact MAUREEN GYLNN
Correspondent
Intel Corporation Digital Health Group
1900 Prairie City Rd.
Fm7-197
Folsom,  CA  95630
Correspondent Contact MAUREEN GYLNN
Regulation Number870.2910
Classification Product Code
DRG  
Date Received11/05/2010
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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