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 ANALYZER

K-Number: K925735 · 1993-12-03

ApplicantBio-Scan, Inc.
Decision Date1993-12-03
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Scan, Inc.. It received FDA 510(k) clearance on 1993-12-03 under 510(k) number K925735. The device is classified under product code GWS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG ANALYZER?

EEG ANALYZER is a medical device that received FDA 510(k) clearance on 1993-12-03. The listed applicant is Bio-Scan, Inc.. The 510(k) number is K925735.

When did EEG ANALYZER receive FDA 510(k) clearance?

EEG ANALYZER received FDA 510(k) clearance on 1993-12-03, under 510(k) number K925735.

Who is the listed applicant for EEG ANALYZER?

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

What is the FDA product code for EEG ANALYZER?

The FDA product code for EEG ANALYZER is GWS.

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-Scan, 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.

K003480BIOFINDK864928BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDERK841685EEG ELECTRODESK841683Q.P. PREAMPLIFIER SYSK841684BIO/SCAN BIOLOG CASSETTE RECORDER

Related Devices (Code: GWS)

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.

K974718PERSYST PRISMPersyst Development Corp.K912938RHYTHMStellate SystemsK894629NICOLET BEAM II SYSTEMNicolet Instrument Corp.K871931ISTAT SOFTWARENeuroscience, Inc.K871480STD-228 SPECTRAL TREND DISPLAYGrass-Telefactor Product GroupK854662OEE_7102 EEG/TREND MONITORNihon Kohden America, 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.

↑