Cleared Traditional

ZOLL E SERIES ALS

K140502 · ZOLL Medical Corporation · Cardiovascular
Nov 2014
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K140502 is an FDA 510(k) clearance for the ZOLL E SERIES ALS, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on November 6, 2014, 252 days after receiving the submission on February 27, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K140502 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2014
Decision Date November 06, 2014
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LDD — Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5300

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