Cleared Traditional

DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE

K030812 · Datex-Ohmeda · Cardiovascular
May 2003
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K030812 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on May 21, 2003, 68 days after receiving the submission on March 14, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K030812 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2003
Decision Date May 21, 2003
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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