510(k) K942040

MRX-280 by Mrx Corp. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1994
Date Received
April 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type