FDA 510(k) Application Details - K111021

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K111021
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	MCUBE TECHNOLOGY CO., LTD. 803 SHINNAE-TECHNOTOWN 485 SANGBONG-DONG CHUNGNANG-KU, SEOUL 131-220 KR Other 510(k) Applications for this Company
Contact	SEUNGTAI KIM 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	04/12/2011
Decision Date	04/27/2011
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	Y
Expedited Review