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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
AusculThing Oy
Ruusutorpanpuisto 4 A 15
Espoo,  FI 02600
Applicant Contact Jani Virtanen
AusculThing Oy
Ruusutorpanpuisto 4 A 15
Espoo,  FI 02600
Correspondent Contact Jani Virtanen
Regulation Number870.1875
Classification Product Code
Subsequent Product Code
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