Cleared Traditional

ZOLL PROPAQ XM

K121367 · ZOLL Medical Corporation · Cardiovascular
Jun 2012
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K121367 is an FDA 510(k) clearance for the ZOLL PROPAQ XM, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on June 21, 2012, 45 days after receiving the submission on May 7, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K121367 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2012
Decision Date June 21, 2012
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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