Cleared Special

DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES

K031781 · Datex-Ohmeda · Cardiovascular
Jun 2003
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K031781 is an FDA 510(k) clearance for the DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) 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 June 25, 2003, 15 days after receiving the submission on June 10, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K031781 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2003
Decision Date June 25, 2003
Days to Decision 15 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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