510(k) K944732

DEXTER ISOKINETIC by Cedaron Medical, Inc. — Product Code IKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1995
Date Received
August 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Isokinetic Testing And Evaluation
Device Class
Class II
Regulation Number
890.1925
Review Panel
PM
Submission Type