Cleared Traditional

NEUROTIPS(TM)

K871571 · Ulster Scientific, Inc. · Neurology
Jun 1987
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K871571 is an FDA 510(k) clearance for the NEUROTIPS(TM), a Esthesiometer (Class I — General Controls, product code GXB), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on June 18, 1987, 57 days after receiving the submission on April 22, 1987. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1500.

Submission Details

510(k) Number K871571 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1987
Decision Date June 18, 1987
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GXB — Esthesiometer
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1500