Cleared Traditional

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

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

Apr 2003

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K030297 is an FDA 510(k) clearance for the FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130, 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 review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K030297 FDA.gov
FDA Decision	Cleared 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