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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
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