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FDA 510(k)

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)

K-Number: K863353 · 1986-11-03

ApplicantGrason-Stadler, Inc.
Decision Date1986-11-03
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) is the device name listed in this FDA 510(k) record. The listed applicant is Grason-Stadler, Inc.. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K863353. 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 MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)?

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K863353.

When did MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) receive FDA 510(k) clearance?

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) received FDA 510(k) clearance on 1986-11-03, under 510(k) number K863353.

Who is the listed applicant for MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)?

The FDA 510(k) record lists Grason-Stadler, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)?

The FDA product code for MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) is ETY.

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Other records listing Grason-Stadler, Inc. 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.

K180287GSI CortiK172403GSI NovusK000097GSI 2000 MIDDLE EAR ANALYZERK974237GSI 70 AUDIOPATH SCREENERK970324GSI SA60 DPOAE SYSTEMK953684GSI 61 CLINICAL AUDIOMETER

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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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