Identifiers
- 510(k) Number
- K884537 FDA 510(k)
- FDA Product Code
- GWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AE-800PA EEG Module is a full-montage standard electroencephalograph. It is designed to record and monitor electrical activity of the brain.
This device is manufactured by Nihon Kohden America, Inc. and has received FDA 510(k) clearance under regulation number 882.1400.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AE-800PA EEG MODULE (K884537) — FDA 510 (k) | Innolitics, AE-800PA EEG MODULE (K884537) - FDA 510 (k), AE-800PA EEG MODULE 510 (k) K884537 - FDA.report, PDF K884537 AE-800PA EEG MODULE - 510kdatabase.net, Nihon Kohden… — 166 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884537 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K884537 24 fields · synced Sep 26, 2026