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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K171056
Device Name WAVE Clinical Platform
Applicant
Excel Medical Electronics, LLC
801 Maplewood Dr.
Ste-25
Jupiter,  FL  33458
Applicant Contact Lance Burton
Correspondent
Excel Medical Electronics, LLC
801 Maplewood Dr.
Ste-25
Jupiter,  FL  33458
Correspondent Contact Lance Burton
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
OUG  
Date Received04/10/2017
Decision Date 01/04/2018
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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