DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER

• K Number: K970659
• Device Name: DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
• Manufacturer: TELEDIAGNOSTIC SYSTEMS, INC.
• Date Cleared: 1997-05-16 ( 84 days)
• Product Code: GYE
• Regulation Number: 882.1855
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 882.1855 Electroencephalogram (EEG) telemetry system.

(a)
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.(b)
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.