(72 days)
The PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), Evoked Potential (EP), or as Ground and Reference in an EEG or EP recording.
Not Found
The provided text is a 510(k) premarket notification document from the FDA regarding a medical device called the "Persyst PressOn™ Electrode." This document determines the substantial equivalence of the device to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The text primarily focuses on:
- FDA's substantial equivalence determination: Stating that the device is substantially equivalent to predicate devices.
- Regulatory information: Such as regulation numbers, product codes, and applicable CFR sections.
- Manufacturer information: Including the company name and contact person.
- Indications for Use statement: Describing the intended use of the Persyst PressOn™ Electrode for recording Electroencephalograms (EEG), Evoked Potentials (EP), or as ground and reference in EEG/EP recordings.
Therefore, I cannot provide the requested table or information about the study, as these details are not present in the provided input.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).