Cleared Special

K131382 - EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL (FDA 510(k) Clearance)

K131382 · Invivo Corporation · Cardiovascular device

Jul 2013

Decision

62d

Days

Class 2

Risk

K131382 is an FDA 510(k) clearance for the EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL. 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 July 15, 2013, 62 days after receiving the submission on May 14, 2013.

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

Submission Details

510(k) Number	K131382 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 2013
Decision Date	July 15, 2013
Days to Decision	62 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