Cleared Traditional

ECG Disposable Lead Wire

K170536 · APK Technology Co., Ltd. · Cardiovascular
Apr 2017
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K170536 is an FDA 510(k) clearance for the ECG Disposable Lead Wire, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by APK Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 24, 2017, 60 days after receiving the submission on February 23, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K170536 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2017
Decision Date April 24, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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