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FDA 510(k)

BRAEGEN EEG TRANSMITTER/RECEIVER SYS

K-Number: K811093 · 1981-05-05

ApplicantElectro-Bio-Medical Services, Inc.
Decision Date1981-05-05
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAEGEN EEG TRANSMITTER/RECEIVER SYS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Bio-Medical Services, Inc.. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K811093. 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 BRAEGEN EEG TRANSMITTER/RECEIVER SYS?

BRAEGEN EEG TRANSMITTER/RECEIVER SYS is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Electro-Bio-Medical Services, Inc.. The 510(k) number is K811093.

When did BRAEGEN EEG TRANSMITTER/RECEIVER SYS receive FDA 510(k) clearance?

BRAEGEN EEG TRANSMITTER/RECEIVER SYS received FDA 510(k) clearance on 1981-05-05, under 510(k) number K811093.

Who is the listed applicant for BRAEGEN EEG TRANSMITTER/RECEIVER SYS?

The FDA 510(k) record lists Electro-Bio-Medical Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAEGEN EEG TRANSMITTER/RECEIVER SYS?

The FDA product code for BRAEGEN EEG TRANSMITTER/RECEIVER SYS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Electro-Bio-Medical Services, 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.

K832304BRAEGEN III 10-CHANNEL TRANSMITTER-

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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