Cleared Traditional

K032582 - UNITY NETWORK PATIENT DATA SERVER (FDA 510(k) Clearance)

K032582 · Ge Medical Systems Information Technologies · Cardiovascular device

Sep 2003

Decision

27d

Days

Class 2

Risk

K032582 is an FDA 510(k) clearance for the UNITY NETWORK PATIENT DATA SERVER. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on September 17, 2003, 27 days after receiving the submission on August 21, 2003.

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

Submission Details

510(k) Number	K032582 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 21, 2003
Decision Date	September 17, 2003
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF