Cleared Traditional

EDI 320

K873599 · Cybex · Neurology
Oct 1987
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K873599 is an FDA 510(k) clearance for the EDI 320, a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on October 16, 1987, 42 days after receiving the submission on September 4, 1987. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number K873599 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1987
Decision Date October 16, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

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