FDA 510(k) Application Details - K231783

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K231783
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	CIVCO Medical Instruments Co., Inc. 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	06/16/2023
Decision Date	11/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review