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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 K182543
Device Name Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
Applicant
Snap40, Ltd.
24 Forth St.
Edinburgh,  GB EH1 3LH
Applicant Contact Edwin Lindsay
Correspondent
Snap40, Ltd.
24 Forth St.
Edinburgh,  GB EH1 3LH
Correspondent Contact Edwin Lindsay
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZQ   DQA   DRG   FLL  
Date Received09/17/2018
Decision Date 11/14/2018
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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