510(k) K030487

R 72 by Ralco S.R.L. — Product Code KPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2003
Date Received
February 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type