Cleared Traditional

SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI

K900472 · Skytron, Div. the Kmw Group, Inc. · Neurology
Sep 1990
Decision
216d
Days
Class 1
Risk

About This 510(k) Submission

K900472 is an FDA 510(k) clearance for the SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI, a Chair, Neurosurgical (Class I — General Controls, product code HBN), submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 4, 1990, 216 days after receiving the submission on January 31, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4125.

Submission Details

510(k) Number K900472 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1990
Decision Date September 04, 1990
Days to Decision 216 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HBN — Chair, Neurosurgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4125