# K970672: Crystal-Eeg Model 10 (Model 10)

- Pathway: 510(k) (Traditional)
- Applicant: Cleveland Medical Devices, Inc.
- Decided: May 22, 1997 after 87 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System: named in the summary without a submission number

## Most influential descendants
- K082886: Zoom-100DC (2009), 11 descendants of its own
- K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (2010), 6 descendants of its own
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own

## Indications for use
The Crystal-EEG Model-10 is a mobile, intermediate range, wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.

Source page: https://510kreport.com/device/K970672
Methodology: https://510kreport.com/methodology