FDA 510(k) Application Details - K030061

Device Classification Name	More FDA Info for this Device
510(K) Number	K030061
Device Name	PS 3000 DIGATAL PHOTOSPOT SYSTEM
Applicant	PRECISE OPTICS 1151 HOPE ST. STAMFORD, CT 06907 US Other 510(k) Applications for this Company
Contact	RICHARD KEEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2003
Decision Date	04/07/2003
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