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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K181248
Device Name Comarch e-Care Platform
Comarch Healthcare SA
al. Jana Pawla II 39a,
Krakow,  PL 31-864
Applicant Contact Irmina Serafin
mdi Consultants, Inc.
55 Northern Blvd, Suite 200
Great Neck,  NY  11021
Correspondent Contact Jigar Shah
Regulation Number870.2910
Classification Product Code
Date Received05/10/2018
Decision Date 10/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No