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FDA 510(k)

M10 EEG MONITOR SCOPE

K-Number: K871120 · 1987-05-01

ApplicantTelediagnostic Systems, Inc.
Decision Date1987-05-01
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

M10 EEG MONITOR SCOPE 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 1987-05-01 under 510(k) number K871120. 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 M10 EEG MONITOR SCOPE?

M10 EEG MONITOR SCOPE is a medical device that received FDA 510(k) clearance on 1987-05-01. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K871120.

When did M10 EEG MONITOR SCOPE receive FDA 510(k) clearance?

M10 EEG MONITOR SCOPE received FDA 510(k) clearance on 1987-05-01, under 510(k) number K871120.

Who is the listed applicant for M10 EEG MONITOR SCOPE?

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 M10 EEG MONITOR SCOPE?

The FDA product code for M10 EEG MONITOR SCOPE 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 SYSTEMK970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERK904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMK904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIERK885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER

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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.K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTelediagnostic Systems, 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.

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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