510(k) K921130

MRX-865 by Mrx-Ray Tube Corp. — Product Code ITY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1992
Date Received
March 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type