Cleared Traditional

K180903 - 3880 MRI Patient Monitoring System (FDA 510(k) Clearance)

K180903 · Iradimed Corporation · Cardiovascular device

Mar 2019

Decision

357d

Days

Class 2

Risk

K180903 is an FDA 510(k) clearance for the 3880 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 Iradimed Corporation (Winter Springs, US). The FDA issued a Cleared decision on March 29, 2019, 357 days after receiving the submission on April 6, 2018.

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

Submission Details

510(k) Number	K180903 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 2018
Decision Date	March 29, 2019
Days to Decision	357 days
Submission Type	Traditional
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