FDA 510(k) Application Details - K960198

Device Classification Name	More FDA Info for this Device
510(K) Number	K960198
Device Name	DIGISCOPE RX-2
Applicant	MEDIREX, INC. 831 BEACON ST. SUITE 227, BOX 9100 NEWTOWN, MA 02159 US Other 510(k) Applications for this Company
Contact	AHAVA STEIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1996
Decision Date	03/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review