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FDA 510(k)

VIDEO EEG OPTION MODIFICATION

K-Number: K933951 · 1994-02-03

ApplicantEsaote Biomedica Spa
Decision Date1994-02-03
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VIDEO EEG OPTION MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Biomedica Spa. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K933951. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDEO EEG OPTION MODIFICATION?

VIDEO EEG OPTION MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Esaote Biomedica Spa. The 510(k) number is K933951.

When did VIDEO EEG OPTION MODIFICATION receive FDA 510(k) clearance?

VIDEO EEG OPTION MODIFICATION received FDA 510(k) clearance on 1994-02-03, under 510(k) number K933951.

Who is the listed applicant for VIDEO EEG OPTION MODIFICATION?

The FDA 510(k) record lists Esaote Biomedica Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIDEO EEG OPTION MODIFICATION?

The FDA product code for VIDEO EEG OPTION MODIFICATION is GWQ.

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 Esaote Biomedica Spa 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.

K902368PERSONAL 120/210 BASIC ELECTROCARDIOGRAPHK896356AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEMK902334MONITOR, MODEL 2817

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

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

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