Cleared Traditional

CARESCAPE MONITOR B850

K131414 · GE Healthcare Finland Oy · Cardiovascular
Aug 2013
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K131414 is an FDA 510(k) clearance for the CARESCAPE MONITOR B850, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on August 28, 2013, 104 days after receiving the submission on May 16, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K131414 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2013
Decision Date August 28, 2013
Days to Decision 104 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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