LogoFDA 510(k) Search
K Number
K000712
Device Name
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
Manufacturer
MEDICAL RESEARCH LABORATORIES, INC.
Date Cleared
2000-04-27

(56 days)

Product Code
CCK,LDD,MKJ,MWI
Regulation Number
868.1400
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).