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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K241217
Device Name CloudHRV™ System (100-01-001)
Applicant
Inmedix, Inc.
17837 First Ave. S., #6
Normandy Park,  WA  98148
Applicant Contact Andrew Holman
Correspondent
Daniel & Daniel Consulting, LLC
P.O. Box 129
Minden,  NV  89423
Correspondent Contact Michael Daniel
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/01/2024
Decision Date 01/16/2025
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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