FDA 510(k) Application Details - K142618

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K142618
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	Hitachi Aloka Medical America, Inc. 10 Fairfield Blvd Wallingford, CT 06492 US Other 510(k) Applications for this Company
Contact	Angela Van Arsdale 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	09/16/2014
Decision Date	10/16/2014
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