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FDA 510(k)

OTOACOUSTIC EMISSIONS UNIT CELESTA 503

K-Number: K931325 · 1994-02-18

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1994-02-18
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOACOUSTIC EMISSIONS UNIT CELESTA 503 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 1994-02-18 under 510(k) number K931325. 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 OTOACOUSTIC EMISSIONS UNIT CELESTA 503?

OTOACOUSTIC EMISSIONS UNIT CELESTA 503 is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K931325.

When did OTOACOUSTIC EMISSIONS UNIT CELESTA 503 receive FDA 510(k) clearance?

OTOACOUSTIC EMISSIONS UNIT CELESTA 503 received FDA 510(k) clearance on 1994-02-18, under 510(k) number K931325.

Who is the listed applicant for OTOACOUSTIC EMISSIONS UNIT CELESTA 503?

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 OTOACOUSTIC EMISSIONS UNIT CELESTA 503?

The FDA product code for OTOACOUSTIC EMISSIONS UNIT CELESTA 503 is EWO.

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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 INSTRUMENTK931324ORBITER 922 CLINICAL AUDIOMETERK910247ZODIAC 901 MIDDLE-EAR ANALYZERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEMK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZERK883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602

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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.

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