Cleared Traditional

K033281 - DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE (FDA 510(k) Clearance)

K033281 · Datex-Ohmeda · Cardiovascular device

Nov 2003

Decision

43d

Days

Class 2

Risk

K033281 is an FDA 510(k) clearance for the DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on November 26, 2003, 43 days after receiving the submission on October 14, 2003.

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

Submission Details

510(k) Number	K033281 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 14, 2003
Decision Date	November 26, 2003
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF