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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 K231551
Device Name Stethophone
Applicant
Sparrow Acoustics Inc.
2416 Natura Dr
Lucasville,  CA B4B0X3
Applicant Contact Nadia Ivanova
Correspondent
Sparrow Acoustics Inc.
2416 Natura Dr
Lucasville,  CA B4B0X3
Correspondent Contact Nadia Ivanova
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/30/2023
Decision Date 10/12/2023
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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