Cleared Special

SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)

K112962 · Spacelabs Medical, Inc. · Cardiovascular
Nov 2011
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K112962 is an FDA 510(k) clearance for the SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on November 2, 2011, 28 days after receiving the submission on October 5, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K112962 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2011
Decision Date November 02, 2011
Days to Decision 28 days
Submission Type Special
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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