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)

MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT

K-Number: K964132 · 1997-05-13

ApplicantBio-Logic Systems Corp.
Decision Date1997-05-13
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT 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 1997-05-13 under 510(k) number K964132. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT?

MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT is a medical device that received FDA 510(k) clearance on 1997-05-13. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K964132.

When did MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT receive FDA 510(k) clearance?

MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT received FDA 510(k) clearance on 1997-05-13, under 510(k) number K964132.

Who is the listed applicant for MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT?

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 MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT?

The FDA product code for MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT is EWO.

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: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, 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.

↑