Cleared Traditional

WIRELESS MONITORING SYSTEM

K110809 · Carefusion 303, Inc. · Cardiovascular

Jul 2011

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K110809 is an FDA 510(k) clearance for the WIRELESS MONITORING SYSTEM, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Carefusion 303, Inc. (Abingdon,Oxon, GB). The FDA issued a Cleared decision on July 5, 2011, 104 days after receiving the submission on March 23, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K110809 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2011
Decision Date	July 05, 2011
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910