Cleared Traditional

Portable ECG Monitor

K170954 · Contec Medical Systems Co.,Ltd · Cardiovascular
May 2017
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K170954 is an FDA 510(k) clearance for the Portable ECG Monitor, 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 May 30, 2017, 60 days after receiving the submission on March 31, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K170954 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2017
Decision Date May 30, 2017
Days to Decision 60 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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