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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K123539
Device Name STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
Applicant
STAYHEALTHY, INC.
24 EAST HUNGTINGTON DRIVE
MONROVIA,  CA  91016
Applicant Contact COLIN HILL PHD.
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
HIT   MNW  
Date Received11/16/2012
Decision Date 04/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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