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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 K080798
Device Name INTEL HEALTH GUIDE, MODEL: PHS6000
Applicant
INTEL CORP.
1900 PRAIRIE CITY RD., FM7-197
FOLSOM,  CA  95630
Applicant Contact TAE-WOONG KOO
Correspondent
INTEL CORP.
1900 PRAIRIE CITY RD., FM7-197
FOLSOM,  CA  95630
Correspondent Contact TAE-WOONG KOO
Regulation Number870.2910
Classification Product Code
DRG  
Date Received03/20/2008
Decision Date 06/27/2008
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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