Cleared Traditional

ZOLL RESCUENET 12-LEAD

K121865 · ZOLL Medical Corporation · Cardiovascular
Nov 2012
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K121865 is an FDA 510(k) clearance for the ZOLL RESCUENET 12-LEAD, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on November 20, 2012, 147 days after receiving the submission on June 26, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K121865 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2012
Decision Date November 20, 2012
Days to Decision 147 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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