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Crystal-EEG Model 15

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001110

by Cleveland Medical Devices Inc.

Identifiers

510(k) Number
K001110 FDA 510(k)
FDA Product Code
OMC 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 Crystal-EEG Model 15 is a Reduced-Montage Standard Electroencephalograph, designed for recording electrical activity in the brain. It captures and displays EEG signals to aid in the diagnosis and monitoring of neurological conditions, such as epilepsy, sleep disorders, and other brain-related abnormalities.

This device is intended for use in clinical settings, including hospitals and neurology clinics, and is supplied as a reusable medical instrument. It operates in non-MRI environments and is regulated under FDA 510(k) clearance (K001110) as a Class II device. The device is authorized for distribution in the United States and adheres to regulatory standards outlined in CFR Title 21, specifically 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: CRYSTAL-EEG MODEL 15 (K001110) — FDA 510(k) | Innolitics, Crystal-eeg Model 15 510 (k) FDA Premarket Notification K001110 ..., 510 (k) Premarket Notification - Food and Drug Administration, Cleveland Medical Devices Inc FDA Filings

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cleveland Medical Devices Inc.
FDA Applicant
Cleveland Medical Devices, Inc.

Sources (1)

  • FDA 510(k) K001110 24 fields · synced Sep 19, 2026