Cleared Traditional

INCLINOMETER

K954647 · J-Tech, Inc. · Neurology
Oct 1995
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K954647 is an FDA 510(k) clearance for the INCLINOMETER, a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by J-Tech, Inc. (Alpine, US). The FDA issued a Cleared decision on October 30, 1995, 20 days after receiving the submission on October 10, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number K954647 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 1995
Decision Date October 30, 1995
Days to Decision 20 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code KQX — Goniometer, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.1500