Cleared Traditional

K071661 - ALPHAONE BIOFEEDBACK SYSTEM (FDA 510(k) Clearance)

K071661 · Telediagnostic Systems, Inc. · Neurology device

Sep 2007

Decision

78d

Days

Class 2

Risk

K071661 is an FDA 510(k) clearance for the ALPHAONE BIOFEEDBACK SYSTEM. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).

Submitted by Telediagnostic Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 5, 2007, 78 days after receiving the submission on June 19, 2007.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number	K071661 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 2007
Decision Date	September 05, 2007
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement