Cleared Traditional

COMPATIBILITY ECG TRUNK CABLES

K043572 · Datex-Ohmeda · Cardiovascular
Feb 2005
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K043572 is an FDA 510(k) clearance for the COMPATIBILITY ECG TRUNK CABLES, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on February 22, 2005, 57 days after receiving the submission on December 27, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K043572 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2004
Decision Date February 22, 2005
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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