Cleared Traditional

CYBEX 6000

K905525 · Cybex · Physical Medicine
Feb 1991
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K905525 is an FDA 510(k) clearance for the CYBEX 6000, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on February 14, 1991, 66 days after receiving the submission on December 10, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K905525 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1990
Decision Date February 14, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

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