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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K173170
Device Name Epicardia Anywhere
Applicant
Medicomp, Inc.
600 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact Sean Marcus
Correspondent
Mdi Consultants
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Susan D. Goldstein-Falk
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/29/2017
Decision Date 01/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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