Cleared Special

K120616 - SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
(FDA 510(k) Clearance)

K120616 · Spacelabs Medical, Inc. · Cardiovascular
Mar 2012
Decision
29d
Days
Class 2
Risk

K120616 is an FDA 510(k) clearance for the SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX).

Submitted by Spacelabs Medical, Inc. (Nederland, US). The FDA issued a Cleared decision on March 29, 2012, 29 days after receiving the submission on February 29, 2012.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K120616 FDA.gov
FDA Decision Cleared SESE
Date Received February 29, 2012
Decision Date March 29, 2012
Days to Decision 29 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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