FDA 510(k) Application Details - K990248

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K990248
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	DICOMIT IMAGING SYSTEMS CORP. 75 EAST BEAVER CREEK RD., #9 RICHMOND HILL, ONTARIO L4B 1K6 CA Other 510(k) Applications for this Company
Contact	TERRY CALLAHAN 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	01/26/1999
Decision Date	04/16/1999
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