Cleared Traditional

Unimed Disposable ECG lead wires

K142489 · Unimed Medical Supplies, Inc. · Cardiovascular
Nov 2014
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K142489 is an FDA 510(k) clearance for the Unimed Disposable ECG lead wires, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on November 4, 2014, 61 days after receiving the submission on September 4, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K142489 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2014
Decision Date November 04, 2014
Days to Decision 61 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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