Cleared Special

K040559 - MODIFICATION TO UNITY NETWORK ID (FDA 510(k) Clearance)

K040559 · Ge Medical Systems Information Technologies · Cardiovascular device

Jun 2004

Decision

93d

Days

Class 2

Risk

K040559 is an FDA 510(k) clearance for the MODIFICATION TO UNITY NETWORK ID. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on June 4, 2004, 93 days after receiving the submission on March 3, 2004.

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

Submission Details

510(k) Number	K040559 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 2004
Decision Date	June 04, 2004
Days to Decision	93 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