Cleared Traditional

CONTEC? Electrocardiograph

K171360 · Contec Medical Systems Co.,Ltd · Cardiovascular
Jan 2018
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K171360 is an FDA 510(k) clearance for the CONTEC? Electrocardiograph, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on January 22, 2018, 258 days after receiving the submission on May 9, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K171360 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2017
Decision Date January 22, 2018
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340

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