Cleared Traditional

K132533 - CARESCAPE MONITOR B450
(FDA 510(k) Clearance)

K132533 · GE Healthcare Finland Oy · Cardiovascular

Dec 2013

Decision

114d

Days

Class 2

Risk

K132533 is an FDA 510(k) clearance for the CARESCAPE MONITOR B450. This device is classified as 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 December 4, 2013, 114 days after receiving the submission on August 12, 2013.

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

Submission Details

510(k) Number	K132533 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2013
Decision Date	December 04, 2013
Days to Decision	114 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