510(k) K973162

DUAL RADIATION TARGETING SYSTEM DRTS DRAPE by Hogan & Hartson — Product Code IWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1997
Date Received
August 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type