Cleared Traditional

DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES

K043551 · Datex-Ohmeda · Cardiovascular
Feb 2005
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K043551 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES, 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 February 18, 2005, 57 days after receiving the submission on December 23, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K043551 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2004
Decision Date February 18, 2005
Days to Decision 57 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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