510(k) K022354

ULTRAGUIDE CTG 2000SA by Ultraguide , Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2002
Date Received
July 19, 2002
Clearance Type
Special
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