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)

SIEGEN VISUAL STIMULATOR

K-Number: K844616 · 1985-02-14

ApplicantSiegen Corp.
Decision Date1985-02-14
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SIEGEN VISUAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Siegen Corp.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K844616. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEGEN VISUAL STIMULATOR?

SIEGEN VISUAL STIMULATOR is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Siegen Corp.. The 510(k) number is K844616.

When did SIEGEN VISUAL STIMULATOR receive FDA 510(k) clearance?

SIEGEN VISUAL STIMULATOR received FDA 510(k) clearance on 1985-02-14, under 510(k) number K844616.

Who is the listed applicant for SIEGEN VISUAL STIMULATOR?

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

What is the FDA product code for SIEGEN VISUAL STIMULATOR?

The FDA product code for SIEGEN VISUAL STIMULATOR is GWE.

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 Siegen Corp. 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.

K871964SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.K861884NEUROSCOPE SEEGK862430SIEGEN HEADPHONESK844646SIEGEN SURFACE ELECTRODESK843464SIEGEN NEUROSCOPE

Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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.

↑