(125 days)
The Smart CapnoLine Guardian™ is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 60 fr. bite block, during upper endoscopy type procedures. The set is intended for single patient use only.
Not Found
I am sorry, but the provided text does not contain specific details about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA to Oridion Medical 1987 Limited regarding their Smart CapnoLine Guardian™ device, confirming its substantial equivalence to a legally marketed predicate device.
It primarily covers:
- Confirmation of substantial equivalence.
- Regulatory information and compliance requirements for the device.
- Contact information for regulatory questions.
- The product's indications for use.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 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).