Cleared Traditional

CYBEX 770

K950095 · Cybex · Physical Medicine
Jun 1995
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K950095 is an FDA 510(k) clearance for the CYBEX 770, 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 June 21, 1995, 162 days after receiving the submission on January 10, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K950095 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1995
Decision Date June 21, 1995
Days to Decision 162 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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