Cleared Special

Philips Efficia CMS200 Central Monitoring System

K160951 · Philips Medical Systems · Cardiovascular
May 2016
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K160951 is an FDA 510(k) clearance for the Philips Efficia CMS200 Central Monitoring System, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on May 5, 2016, 30 days after receiving the submission on April 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K160951 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2016
Decision Date May 05, 2016
Days to Decision 30 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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