Cleared Traditional

K061799 - QUADRATENS, MODEL QT-42
(FDA 510(k) Clearance)

K061799 · Bio-Research Associates, Inc. · Neurology

Aug 2006

Decision

63d

Days

Class 2

Risk

K061799 is an FDA 510(k) clearance for the QUADRATENS, MODEL QT-42, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Bio-Research Associates, Inc. (Brown Deer, US). The FDA issued a Cleared decision on August 28, 2006, 63 days after receiving the submission on June 26, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K061799 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2006
Decision Date	August 28, 2006
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF