Cleared Traditional

DEXTER ISOKINETIC

K944732 · Cedaron Medical, Inc. · Physical Medicine
Feb 1995
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K944732 is an FDA 510(k) clearance for the DEXTER ISOKINETIC, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Cedaron Medical, Inc. (Davis, US). The FDA issued a Cleared decision on February 3, 1995, 162 days after receiving the submission on August 25, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K944732 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1994
Decision Date February 03, 1995
Days to Decision 162 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IKK — System, Isokinetic Testing And Evaluation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1925