Cleared Traditional

ZOLL CODE WRITER

K132488 · ZOLL Medical Corporation · Cardiovascular
Apr 2014
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K132488 is an FDA 510(k) clearance for the ZOLL CODE WRITER, 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 April 3, 2014, 238 days after receiving the submission on August 8, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K132488 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2013
Decision Date April 03, 2014
Days to Decision 238 days
Submission Type Traditional
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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