FDA 510(k) Application Details - K123209

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K123209
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE PLYMOUTH, MI 48170 US Other 510(k) Applications for this Company
Contact	ANDREA N WALLEN Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2012
Decision Date	12/19/2013
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