Cleared Traditional

K103336 - MPS450 MULTIPARAMETER SIMULATOR
(FDA 510(k) Clearance)

K103336 · Fluke Biomedical · Cardiovascular

Apr 2011

Decision

149d

Days

Class 2

Risk

K103336 is an FDA 510(k) clearance for the MPS450 MULTIPARAMETER SIMULATOR. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT).

Submitted by Fluke Biomedical (Cleveland, US). The FDA issued a Cleared decision on April 13, 2011, 149 days after receiving the submission on November 15, 2010.

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

Submission Details

510(k) Number	K103336 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2010
Decision Date	April 13, 2011
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF