Cleared Traditional

K030297 - FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 (FDA 510(k) Clearance)

K030297 · Enraf-Nonius, B.V. · Neurology device

Apr 2003

Decision

90d

Days

Class 2

Risk

K030297 is an FDA 510(k) clearance for the FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).

Submitted by Enraf-Nonius, B.V. (Delft, NL). The FDA issued a Cleared decision on April 28, 2003, 90 days after receiving the submission on January 28, 2003.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K030297 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 28, 2003
Decision Date	April 28, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF