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)

MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM

K-Number: K884371 · 1989-02-13

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1989-02-13
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Madsen Electronics (Canada) , Ltd.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K884371. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM?

MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K884371.

When did MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM receive FDA 510(k) clearance?

MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM received FDA 510(k) clearance on 1989-02-13, under 510(k) number K884371.

Who is the listed applicant for MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM?

The FDA 510(k) record lists Madsen Electronics (Canada) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM?

The FDA product code for MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM is ETW.

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 Madsen Electronics (Canada) , Ltd. 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.

K942749HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENTK931325OTOACOUSTIC EMISSIONS UNIT CELESTA 503K931324ORBITER 922 CLINICAL AUDIOMETERK910247ZODIAC 901 MIDDLE-EAR ANALYZERK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZERK883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602

View all 17 devices →

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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.

↑