Cleared Special

DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES

K041772 · Datex-Ohmeda · Cardiovascular
Jul 2004
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K041772 is an FDA 510(k) clearance for the DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) 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 July 28, 2004, 27 days after receiving the submission on July 1, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K041772 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2004
Decision Date July 28, 2004
Days to Decision 27 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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