← Product Code [GYE](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE) · K883461

# DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES (K883461)

_Biohm, Inc. · GYE · Nov 30, 1988 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K883461

## Device Facts

- **Applicant:** Biohm, Inc.
- **Product Code:** [GYE](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE.md)
- **Decision Date:** Nov 30, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1855
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K883461](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K883461)

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