Cleared Traditional

ALGESIOMETER

K801907 · Rowan Products, Inc. · Neurology
Sep 1980
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K801907 is an FDA 510(k) clearance for the ALGESIOMETER, a Esthesiometer (Class I — General Controls, product code GXB), submitted by Rowan Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 36 days after receiving the submission on August 11, 1980. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1500.

Submission Details

510(k) Number K801907 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1980
Decision Date September 16, 1980
Days to Decision 36 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