Cleared Special

DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE

K023497 · Datex-Ohmeda · Cardiovascular
Nov 2002
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K023497 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 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 4, 2002, 17 days after receiving the submission on October 18, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K023497 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2002
Decision Date November 04, 2002
Days to Decision 17 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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