FDA 510(k) Application Details - K001016

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K001016
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	GE MEDICAL SYSTEMS P.O. BOX 414 MILWAUKEE, WI 53188 US Other 510(k) Applications for this Company
Contact	ALLEN SCHUH 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	03/29/2000
Decision Date	04/24/2000
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