Cleared Special

ZOLL EPCR IOS

K131919 · ZOLL Medical Corporation · Cardiovascular
Dec 2013
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K131919 is an FDA 510(k) clearance for the ZOLL EPCR IOS, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on December 17, 2013, 174 days after receiving the submission on June 26, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K131919 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2013
Decision Date December 17, 2013
Days to Decision 174 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXJ — Display, Cathode-ray Tube, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2450

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