(84 days)
The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
Mark 5 Nuvo 8 OCSI
Mark 5 Nuvo 8 STD
I'm sorry, but this document does not contain the information requested. This is an FDA 510(k) clearance letter for the Mark 5 Nuvo 8 OCSI and Mark 5 Nuvo 8 STD portable oxygen generators. It states that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. However, it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any information related to AI or MRMC comparative effectiveness studies. This type of information would typically be found in the 510(k) submission itself, not the clearance letter.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).