Cleared Traditional

UNIVERSAL GONIMETER

K810441 · Fred Sammons, Inc. · Neurology
Feb 1981
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K810441 is an FDA 510(k) clearance for the UNIVERSAL GONIMETER, a Goniometer, Nonpowered (Class I — General Controls, product code KQW), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1981, 8 days after receiving the submission on February 19, 1981. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1520.

Submission Details

510(k) Number K810441 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1981
Decision Date February 27, 1981
Days to Decision 8 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