(219 days)
The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmcter (1 to 12 I.PM). The device is a prescription device and is intended for use within the hospital or institutional environment.
SK Med M202 Mixer
This is an FDA premarket notification (510(k)) letter for the SK Med M202 Mixer. While it confirms clearance for the device, it does not contain the information requested about acceptance criteria and a study proving device performance.
The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and is thus cleared for marketing. It outlines regulatory requirements and general information but does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study (sample size, data provenance, ground truth, expert qualifications, adjudication methods, etc.).
- Information on MRMC comparative effectiveness or standalone algorithm performance.
- Training set details.
Therefore, I cannot provide the requested information from this document.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).