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FDA 510(k)

HEARING AID TEST SYSTEM MODEL HAT 1000

K-Number: K870229 · 1987-03-13

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1987-03-13
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID TEST SYSTEM MODEL HAT 1000 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 1987-03-13 under 510(k) number K870229. 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 HEARING AID TEST SYSTEM MODEL HAT 1000?

HEARING AID TEST SYSTEM MODEL HAT 1000 is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K870229.

When did HEARING AID TEST SYSTEM MODEL HAT 1000 receive FDA 510(k) clearance?

HEARING AID TEST SYSTEM MODEL HAT 1000 received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870229.

Who is the listed applicant for HEARING AID TEST SYSTEM MODEL HAT 1000?

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 HEARING AID TEST SYSTEM MODEL HAT 1000?

The FDA product code for HEARING AID TEST SYSTEM MODEL HAT 1000 is ETW.

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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: 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.

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