Cleared Traditional

HAND HELD GONIOMETER

K850082 · Chattanooga Group, Inc. · Neurology
Apr 1985
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K850082 is an FDA 510(k) clearance for the HAND HELD GONIOMETER, a Goniometer, Nonpowered (Class I — General Controls, product code KQW), submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on April 4, 1985, 84 days after receiving the submission on January 10, 1985. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1520.

Submission Details

510(k) Number K850082 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1985
Decision Date April 04, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code KQW — Goniometer, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.1520