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)

BELTONE SERIES 100 AUDIOMETERS

K-Number: K940216 · 1994-07-29

ApplicantBeltone Electronics Corp.
Decision Date1994-07-29
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BELTONE SERIES 100 AUDIOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Beltone Electronics Corp.. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K940216. 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 BELTONE SERIES 100 AUDIOMETERS?

BELTONE SERIES 100 AUDIOMETERS is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K940216.

When did BELTONE SERIES 100 AUDIOMETERS receive FDA 510(k) clearance?

BELTONE SERIES 100 AUDIOMETERS received FDA 510(k) clearance on 1994-07-29, under 510(k) number K940216.

Who is the listed applicant for BELTONE SERIES 100 AUDIOMETERS?

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

What is the FDA product code for BELTONE SERIES 100 AUDIOMETERS?

The FDA product code for BELTONE SERIES 100 AUDIOMETERS 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 Beltone Electronics 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.

K971852AIR CONDUCTION HAEARING AIDSK963958IMPRESS, PERFECTA, ACU-FORM, AND ACUFITK955930BELTONE COMPOSER 2000 BTE HPK954936BELTONE ULTIMA 80 OTOSONIC POWER PASK943616BELTONE PERSONAL HEARING SCREENERK951587BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K

View all 42 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.

↑