Electrode, Nasopharyngeal
The Nasopharyngeal Electrode is a recording electrode designed to be placed in the nasopharynx to capture electrical activity from the inferior and medial temporal lobe regions of the brain, used as an adjunct in electroencephalographic studies for localizing seizure foci. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZK under regulation 21 CFR 882.1340 in the Neurology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GZK
- Device Class
- FDA class 2
- Regulation Number
- 882.1340
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.