Cleared Traditional

K143676 - B40i Patient Monitor
(FDA 510(k) Clearance)

K143676 · GE Healthcare Finland Oy · Cardiovascular

Jul 2015

Decision

219d

Days

Class 2

Risk

K143676 is an FDA 510(k) clearance for the B40i Patient Monitor. 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 July 31, 2015, 219 days after receiving the submission on December 24, 2014.

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

Submission Details

510(k) Number	K143676 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 24, 2014
Decision Date	July 31, 2015
Days to Decision	219 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