Cleared Special

K033672 - MODIFICATION TO UNITY NETWORK ID (FDA 510(k) Clearance)

K033672 · Ge Medical Systems Information Technologies · Cardiovascular device

Dec 2003

Decision

24d

Days

Class 2

Risk

K033672 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 December 18, 2003, 24 days after receiving the submission on November 24, 2003.

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

Submission Details

510(k) Number	K033672 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 24, 2003
Decision Date	December 18, 2003
Days to Decision	24 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