Cleared Traditional

ZOLL R SERIES

K081574 · ZOLL Medical Corporation · Cardiovascular
Sep 2008
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K081574 is an FDA 510(k) clearance for the ZOLL R SERIES, 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 September 18, 2008, 105 days after receiving the submission on June 5, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K081574 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2008
Decision Date September 18, 2008
Days to Decision 105 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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