Cleared Traditional

SOMATOSENSORY STIMULUS SYSTEM

K913604 · Biomagnetic Technologies, Inc. · Neurology
Dec 1991
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K913604 is an FDA 510(k) clearance for the SOMATOSENSORY STIMULUS SYSTEM, a Stimulator, Mechanical, Evoked Response (Class II — Special Controls, product code GZP), submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1991, 117 days after receiving the submission on August 14, 1991. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1880.

Submission Details

510(k) Number K913604 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1991
Decision Date December 09, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GZP — Stimulator, Mechanical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1880