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FDA 510(k)

HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT

K-Number: K942749 · 1994-07-18

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1994-07-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT 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 1994-07-18 under 510(k) number K942749. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT?

HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K942749.

When did HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT receive FDA 510(k) clearance?

HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT received FDA 510(k) clearance on 1994-07-18, under 510(k) number K942749.

Who is the listed applicant for HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT?

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 HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT?

The FDA product code for HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT is ESD.

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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.

K931325OTOACOUSTIC EMISSIONS UNIT CELESTA 503K931324ORBITER 922 CLINICAL AUDIOMETERK910247ZODIAC 901 MIDDLE-EAR ANALYZERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEMK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZERK883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602

View all 17 devices →

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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.

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