Cleared Traditional

DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES

K992323 · Datex-Ohmeda, Inc. · Cardiovascular
Nov 1999
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K992323 is an FDA 510(k) clearance for the DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES, a Monitor, St Segment With Alarm (Class II — Special Controls, product code MLD), submitted by Datex-Ohmeda, Inc. (Tewksburt, US). The FDA issued a Cleared decision on November 1, 1999, 112 days after receiving the submission on July 12, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K992323 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1999
Decision Date November 01, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code MLD — Monitor, St Segment With Alarm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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