FDA 510(k) Application Details - K233109

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K233109
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	CIVCO Medical Solutions 102 First Street South Kalona, IA 52247 US Other 510(k) Applications for this Company
Contact	James Leong Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	12/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review