FDA 510(k) Application Details - K965013

Device Classification Name	More FDA Info for this Device
510(K) Number	K965013
Device Name	DIGISCOPE RX-2 (9 OPTION)
Applicant	MEDIREX, INC. 49 WALNUT PARK WELLESLEY HILLS, MA 02181 US Other 510(k) Applications for this Company
Contact	YAEL RUBIN 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	12/16/1996
Decision Date	01/17/1997
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