510(k) K911873

X-MARX by Macbrud Corp. Medical Div. — Product Code JAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1991
Date Received
April 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Film Marking, Radiographic
Device Class
Class I
Regulation Number
892.1640
Review Panel
RA
Submission Type