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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K190073
Device Name Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Applicant
Current Health , Ltd.
Playfair House, 12a Broughton St. Lane
Edinburgh,  GB EH1 3LY
Applicant Contact Edwin Lindsay
Correspondent
Current Health , Ltd.
Playfair House, 12a Broughton St. Lane
Edinburgh,  GB EH1 3LY
Correspondent Contact Edwin Lindsay
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZQ   DQA   DRG   FLL  
Date Received01/16/2019
Decision Date 03/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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