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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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