Cleared Traditional

AESTHESIOMETER

K761133 · Fred Sammons, Inc. · Neurology
Dec 1976
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K761133 is an FDA 510(k) clearance for the AESTHESIOMETER, a Esthesiometer (Class I — General Controls, product code GXB), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976, 13 days after receiving the submission on November 19, 1976. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1500.

Submission Details

510(k) Number K761133 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1976
Decision Date December 02, 1976
Days to Decision 13 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