510(k) K891090

SPECBOARD by Macbrud Corp. Medical Div. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1989
Date Received
March 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type