(112 days)
The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients.
Impedance Respiration measurement is indicated for patients ages 3 and up.
Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up.
The monitor is indicated for usc by qualified medical personnel only.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Cardiocap 5". It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed information about the specific acceptance criteria or the study data that proves the device meets those criteria.
The letter focuses on regulatory approval, listing product codes, indications for use, and general regulatory requirements. It doesn't include the technical details of performance studies.
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual 510(k) submission, which would contain the performance data and details about the studies conducted by Datex-Ohmeda, Inc.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.