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FDA 510(k)

ZODIAC 901 MIDDLE-EAR ANALYZER

K-Number: K910247 · 1991-06-19

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1991-06-19
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ZODIAC 901 MIDDLE-EAR ANALYZER 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 1991-06-19 under 510(k) number K910247. 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 ZODIAC 901 MIDDLE-EAR ANALYZER?

ZODIAC 901 MIDDLE-EAR ANALYZER is a medical device that received FDA 510(k) clearance on 1991-06-19. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K910247.

When did ZODIAC 901 MIDDLE-EAR ANALYZER receive FDA 510(k) clearance?

ZODIAC 901 MIDDLE-EAR ANALYZER received FDA 510(k) clearance on 1991-06-19, under 510(k) number K910247.

Who is the listed applicant for ZODIAC 901 MIDDLE-EAR ANALYZER?

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 ZODIAC 901 MIDDLE-EAR ANALYZER?

The FDA product code for ZODIAC 901 MIDDLE-EAR ANALYZER is ETY.

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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 AUDIOMETERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEMK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZERK883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602

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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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