FDA 510(k) Application Details - K202035

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K202035
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics, Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Tracey Ortiz 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	07/23/2020
Decision Date	11/20/2020
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