510(k) K964952

VERIDOSE V (FIVE), MODEL NUMBER 37-705 by Victoreen, Inc. — Product Code JAD

K964952 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "VERIDOSE V (FIVE), MODEL NUMBER 37-705". The FDA issued a decision of Substantially Equivalent on July 21, 1997. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1997
Date Received
December 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type