Cleared Traditional

CC RIDER, MODEL ME180

K951916 · Mettler Electronics Corp. · Physical Medicine
Oct 1995
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K951916 is an FDA 510(k) clearance for the CC RIDER, MODEL ME180, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on October 4, 1995, 163 days after receiving the submission on April 24, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K951916 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1995
Decision Date October 04, 1995
Days to Decision 163 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