Cleared Traditional

ZOLL RESCUENETLINK

K111296 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular
Oct 2011
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K111296 is an FDA 510(k) clearance for the ZOLL RESCUENETLINK, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Zoll Medical Corporation, World Wide Headquarters (Chelmsford, US). The FDA issued a Cleared decision on October 27, 2011, 171 days after receiving the submission on May 9, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K111296 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2011
Decision Date October 27, 2011
Days to Decision 171 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MSX — System, Network And Communication, Physiological Monitors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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