(18 days)
The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.
Hand Held CO2 Monitor (Capnometer) Model: MTEK-80
This document is a 510(k) premarket notification decision letter from the FDA for a Hand-Held CO2 Monitor (Capnometer), Model 80. It approves the device for marketing.
Unfortunately, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The letter is a regulatory approval document and focuses on the substantial equivalence of the device to a predicate device, the regulatory class, and the general controls that apply. It outlines the indications for use of the device, which are:
- As a transportable capnometer.
- Providing End-Tidal CO2, respiration rate, and real-time breath indications.
- For use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room.
- For patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.
To answer your request, I would need a different document, specifically a study report or a summary of performance data that would typically be included in the 510(k) submission itself, but is not present in this decision letter.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).