Cleared Special

K152330 - Expression MR400 MRI Patient Monitoring System (FDA 510(k) Clearance)

K152330 · Invivo Corporation · Cardiovascular device

Dec 2015

Decision

127d

Days

Class 2

Risk

K152330 is an FDA 510(k) clearance for the Expression MR400 MRI Patient Monitoring System. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Invivo Corporation (Orlando, US). The FDA issued a Cleared decision on December 23, 2015, 127 days after receiving the submission on August 18, 2015.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K152330 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 2015
Decision Date	December 23, 2015
Days to Decision	127 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.2300