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)

EVOKED POTENTIAL SYS

K-Number: K842543 · 1984-11-29

ApplicantBio-Logic Systems Corp.
Decision Date1984-11-29
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EVOKED POTENTIAL SYS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K842543. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOKED POTENTIAL SYS?

EVOKED POTENTIAL SYS is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K842543.

When did EVOKED POTENTIAL SYS receive FDA 510(k) clearance?

EVOKED POTENTIAL SYS received FDA 510(k) clearance on 1984-11-29, under 510(k) number K842543.

Who is the listed applicant for EVOKED POTENTIAL SYS?

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

What is the FDA product code for EVOKED POTENTIAL SYS?

The FDA product code for EVOKED POTENTIAL SYS is GWF.

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 Bio-Logic Systems 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.

K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMK061744COCHLEA-SCAN / COCHLEA-SCAN PLUSK052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERK031352BIO-LOGIC INSERT EARPHONES

View all 45 devices →

Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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.

↑