Cleared Abbreviated

INTCO TAB ELECTRODE

K093327 · Shanghai Intco Electrode Manufacturing Co., Ltd. · Cardiovascular
May 2010
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K093327 is an FDA 510(k) clearance for the INTCO TAB ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Shanghai Intco Electrode Manufacturing Co., Ltd. (Sandpoint, US). The FDA issued a Cleared decision on May 10, 2010, 196 days after receiving the submission on October 26, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K093327 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2009
Decision Date May 10, 2010
Days to Decision 196 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

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