Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EEG BIOFEEDBACK DEVICE

K-Number: K842022 · 1984-07-20

ApplicantElectronics Research & Production
Decision Date1984-07-20
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG BIOFEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Electronics Research & Production. It received FDA 510(k) clearance on 1984-07-20 under 510(k) number K842022. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG BIOFEEDBACK DEVICE?

EEG BIOFEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Electronics Research & Production. The 510(k) number is K842022.

When did EEG BIOFEEDBACK DEVICE receive FDA 510(k) clearance?

EEG BIOFEEDBACK DEVICE received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842022.

Who is the listed applicant for EEG BIOFEEDBACK DEVICE?

The FDA 510(k) record lists Electronics Research & Production as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EEG BIOFEEDBACK DEVICE?

The FDA product code for EEG BIOFEEDBACK DEVICE is HCC.

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 Electronics Research & Production 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.

K842021EEG BIOFEEDBACK DEVICE ACCESSORYK842023TEMP. & GSR BIOFEEDBACK DEVICE

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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.

↑