(247 days)
The PulmoScan is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). PulmoScan is intended for use with pediatic and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.
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This is an FDA 510(k) clearance letter for a medical device called PulmoScan. The letter confirms that the device is substantially equivalent to legally marketed predicate devices. The provided text, however, does not contain details about acceptance criteria or a study proving the device meets those criteria.
The document primarily covers:
- The FDA's decision to clear the device (K191876).
- The trade/device name (PulmoScan) and regulatory information (Regulation Number, Name, Class, Product Code).
- General regulatory requirements for marketed devices.
- Indications for Use for the PulmoScan device.
To answer your request, I would need additional information, specifically from a section of the 510(k) submission that details the performance testing and acceptance criteria. This information is typically found in the "Performance Data" or "Clinical Data" sections of a 510(k) summary or the full submission, which is not included in the provided FDA clearance letter.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).