Cleared Traditional

VSA 3000 VIBRATORYN SENSORY ANALYZER

K970180 · Eare Consulting Service · Neurology

Apr 1997

Decision

98d

Days

Class 1

Risk

About This 510(k) Submission

K970180 is an FDA 510(k) clearance for the VSA 3000 VIBRATORYN SENSORY ANALYZER, a Device, Vibration Threshold Measurement (Class I — General Controls, product code LLN), submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on April 25, 1997, 98 days after receiving the submission on January 17, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1200.

Submission Details

510(k) Number	K970180 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1997
Decision Date	April 25, 1997
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF