(80 days)
An electroencephalogram (EEG) electrode array intended for use in the ER, ICU, and OR for recording of STAT EEGs in patients of 18 years of age and older.
An electroencephalogram (EEG) electrode array
This letter addresses the 510(k) premarket notification for the "EEG-Now" device (K180524), which is an electroencephalogram (EEG) electrode array. As a 510(k) summary, it declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or supporting studies.
Therefore, for your request, I must state:
The provided document (K180524 510(k) letter) does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria.
A 510(k) letter from the FDA primarily serves to inform the manufacturer that their device has been determined to be "substantially equivalent" to a legally marketed predicate device. This determination is based on information provided in the original 510(k) submission, which would include performance data, but the letter itself does not detail that data or the specific acceptance criteria.
To find the information you're looking for, you would typically need to consult the original 510(k) submission document itself, which often includes a detailed summary of safety and effectiveness, including performance testing results and acceptance criteria. However, that specific document is not part of the provided text.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).