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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K141862
Device Name HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
Applicant
H2 Inc.
29222 RANCHO VIEJO RD, STE 218
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact Feng-Yu Lee
Correspondent
H2 Inc.
29222 RANCHO VIEJO RD, STE 218
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received07/10/2014
Decision Date 12/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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