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FDA 510(k)

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

K-Number: K970659 · 1997-05-16

ApplicantTelediagnostic Systems, Inc.
Decision Date1997-05-16
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Telediagnostic Systems, Inc.. It received FDA 510(k) clearance on 1997-05-16 under 510(k) number K970659. The device is classified under product code GYE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER?

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K970659.

When did DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER receive FDA 510(k) clearance?

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER received FDA 510(k) clearance on 1997-05-16, under 510(k) number K970659.

Who is the listed applicant for DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER?

The FDA 510(k) record lists Telediagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER?

The FDA product code for DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER is GYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Telediagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071661ALPHAONE BIOFEEDBACK SYSTEMK022249NIGHTRON POLYSOMNOGRAPHY SYSTEMK904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMK904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIERK885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERK884891OC-100 OXIMETER INTERFACE CALIBRATOR

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Related Devices (Code: GYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963195WIRELESS EEG RECORDING SYSTEM MODEL W32Cme Telemetrix, Inc.K895895MODEL 219 TELEMETRY SYSTEMMennen Medical, Inc.K891405BMS-2000 MOBILE EEG SYSTEMBuckman Co., Inc.K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTelediagnostic Systems, Inc.K883947ISO-100 ISOLATION AMPLIFIERTelediagnostic Systems, Inc.K883461DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIESBiohm, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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