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FDA 510(k)

EARCHECK PRO

K-Number: K970685 · 1997-05-28

ApplicantMdi Instruments, Inc.
Decision Date1997-05-28
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARCHECK PRO is the device name listed in this FDA 510(k) record. The listed applicant is Mdi Instruments, Inc.. It received FDA 510(k) clearance on 1997-05-28 under 510(k) number K970685. 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 EARCHECK PRO?

EARCHECK PRO is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Mdi Instruments, Inc.. The 510(k) number is K970685.

When did EARCHECK PRO receive FDA 510(k) clearance?

EARCHECK PRO received FDA 510(k) clearance on 1997-05-28, under 510(k) number K970685.

Who is the listed applicant for EARCHECK PRO?

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

What is the FDA product code for EARCHECK PRO?

The FDA product code for EARCHECK PRO is ETY.

Related Clinical Trials

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.

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Other records listing Mdi Instruments, 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.

K971859EARCHECK

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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