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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 K172739
Device Name higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
Applicant
higi SH LLC
800 Royal Oaks Dr.
Suite 102 and 106
monrovia,  CA  91016
Applicant Contact colin hill
Correspondent
higi SH LLC
800 Royal Oaks Dr.
Suite 102 and 106
monrovia,  CA  91016
Correspondent Contact colin hill
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/12/2017
Decision Date 10/10/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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