Cleared Special

GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3

K042771 · Datex-Ohmeda · Cardiovascular
Oct 2004
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K042771 is an FDA 510(k) clearance for the GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3, 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 October 15, 2004, 10 days after receiving the submission on October 5, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K042771 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2004
Decision Date October 15, 2004
Days to Decision 10 days
Submission Type Special
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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