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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K223166
Device Name Medaica M1 Telehealth Stethoscope
Applicant
Medaica, Inc.
170 S. Green Valley Pkwy. Suite 300
Henderson,  NV  89012
Applicant Contact Stephen Randall
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.1875
Classification Product Code
DQD  
Date Received10/07/2022
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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