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FDA 510(k) Application Details - K230823
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K230823
Device Name
Stethoscope, Electronic
Applicant
AusculThing Oy
Ruusutorpanpuisto 4 A 15
Espoo 02600 FI
Other 510(k) Applications for this Company
Contact
Jani Virtanen
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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