Cleared Traditional

K955026 - AS/3 NMT MODULE
(FDA 510(k) Clearance)

K955026 · Datex Medical Instrumentation, Inc. · Anesthesiology

Apr 1997

Decision

543d

Days

Class 2

Risk

K955026 is an FDA 510(k) clearance for the AS/3 NMT MODULE. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI).

Submitted by Datex Medical Instrumentation, Inc. (Tewksbury, US). The FDA issued a Cleared decision on April 28, 1997, 543 days after receiving the submission on November 2, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number	K955026 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1995
Decision Date	April 28, 1997
Days to Decision	543 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF