Cleared Traditional

DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE

K033281 · Datex-Ohmeda · Cardiovascular
Nov 2003
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K033281 is an FDA 510(k) clearance for the DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE, 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 review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K033281 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MSX — System, Network And Communication, Physiological Monitors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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