Cleared Traditional

CARESCAPE MONITOR B650

K102239 · GE Healthcare Finland Oy · Cardiovascular
Oct 2010
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K102239 is an FDA 510(k) clearance for the CARESCAPE MONITOR B650, 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 October 18, 2010, 70 days after receiving the submission on August 9, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K102239 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2010
Decision Date October 18, 2010
Days to Decision 70 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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