510(k) K934519

RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM by Medtec, Inc. — Product Code IWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1993
Date Received
September 17, 1993
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