FDA 510(k) Application Details - K230823

Device Classification Name Stethoscope, Electronic

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510(K) Number K230823
Device Name Stethoscope, Electronic
Applicant AusculThing Oy
Ruusutorpanpuisto 4 A 15
Espoo 02600 FI
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Contact Jani Virtanen
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 03/24/2023
Decision Date 07/12/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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