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FDA 510(k)

DIGITAL SCREENING AUDIOMETER DSA6214

K-Number: K854534 · 1986-02-13

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1986-02-13
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DIGITAL SCREENING AUDIOMETER DSA6214 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 1986-02-13 under 510(k) number K854534. 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 DIGITAL SCREENING AUDIOMETER DSA6214?

DIGITAL SCREENING AUDIOMETER DSA6214 is a medical device that received FDA 510(k) clearance on 1986-02-13. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K854534.

When did DIGITAL SCREENING AUDIOMETER DSA6214 receive FDA 510(k) clearance?

DIGITAL SCREENING AUDIOMETER DSA6214 received FDA 510(k) clearance on 1986-02-13, under 510(k) number K854534.

Who is the listed applicant for DIGITAL SCREENING AUDIOMETER DSA6214?

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 DIGITAL SCREENING AUDIOMETER DSA6214?

The FDA product code for DIGITAL SCREENING AUDIOMETER DSA6214 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 INSTRUMENTK931325OTOACOUSTIC EMISSIONS UNIT CELESTA 503K931324ORBITER 922 CLINICAL AUDIOMETERK910247ZODIAC 901 MIDDLE-EAR ANALYZERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEMK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZER

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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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