Cleared Traditional

K090198 - JIAJIAN SELF-ADHESIVE ELECTRODE
(FDA 510(k) Clearance)

K090198 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology

Jun 2009

Decision

147d

Days

Class 2

Risk

K090198 is an FDA 510(k) clearance for the JIAJIAN SELF-ADHESIVE ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on June 23, 2009, 147 days after receiving the submission on January 27, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K090198 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2009
Decision Date	June 23, 2009
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF