Cleared Traditional

HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM

K090610 · Hospira, Inc. · Cardiovascular

Mar 2009

Decision

Days

Class 2

Risk

About This 510(k) Submission

K090610 is an FDA 510(k) clearance for the HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 13, 2009, 7 days after receiving the submission on March 6, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K090610 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2009
Decision Date	March 13, 2009
Days to Decision	7 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