Cleared Special

K092680 - DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN
(FDA 510(k) Clearance)

K092680 · GE Healthcare Finland Oy · Cardiovascular
Sep 2009
Decision
22d
Days
Class 2
Risk

K092680 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on September 23, 2009, 22 days after receiving the submission on September 1, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K092680 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2009
Decision Date September 23, 2009
Days to Decision 22 days
Submission Type Special
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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