FDA 510(k) Application Details - K233976

Device Classification Name	Transducer, Ultrasonic   More FDA Info for this Device
510(K) Number	K233976
Device Name	Transducer, Ultrasonic
Applicant	CorVascular Diagnostics, LLC 600 Twelve Oaks Center Drive Suite 102 Wayzata, MN 55391 US Other 510(k) Applications for this Company
Contact	Spencer Lien Other 510(k) Applications for this Contact
Regulation Number	870.2880   More FDA Info for this Regulation Number
Classification Product Code	JOP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2023
Decision Date	07/19/2024
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