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FDA 510(k)

Z0174, IMPEDANCE AUDIOMETER

K-Number: K845049 · 1985-05-21

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1985-05-21
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Z0174, IMPEDANCE AUDIOMETER 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 1985-05-21 under 510(k) number K845049. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z0174, IMPEDANCE AUDIOMETER?

Z0174, IMPEDANCE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K845049.

When did Z0174, IMPEDANCE AUDIOMETER receive FDA 510(k) clearance?

Z0174, IMPEDANCE AUDIOMETER received FDA 510(k) clearance on 1985-05-21, under 510(k) number K845049.

Who is the listed applicant for Z0174, IMPEDANCE AUDIOMETER?

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 Z0174, IMPEDANCE AUDIOMETER?

The FDA product code for Z0174, IMPEDANCE AUDIOMETER is ETY.

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 OPTIMIZERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM

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Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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.

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