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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 K220099
Device Name eClinic Stethopod
Applicant
HomeDiagnostic LLC
3160 De La Cruz Blvd
Suite 100
Santa Clara,  CA  95054
Applicant Contact Jian Gong
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.1875
Classification Product Code
DQD  
Date Received01/12/2022
Decision Date 10/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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