FDA 510(k) Application Details - K141093

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K141093
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 HORTEN N-3183 NO Other 510(k) Applications for this Company
Contact	BRYAN BEHN 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	04/28/2014
Decision Date	05/15/2014
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