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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 K230823
Device Name AusculThing ACC
Applicant
AusculThing Oy
Ruusutorpanpuisto 4 A 15
Espoo,  FI 02600
Applicant Contact Jani Virtanen
Correspondent
AusculThing Oy
Ruusutorpanpuisto 4 A 15
Espoo,  FI 02600
Correspondent Contact Jani Virtanen
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received03/24/2023
Decision Date 07/12/2023
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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