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FDA 510(k)

AMPLAID AM50

K-Number: K974235 · 1998-02-10

ApplicantAmplifon S.P.A.
Decision Date1998-02-10
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMPLAID AM50 is the device name listed in this FDA 510(k) record. The listed applicant is Amplifon S.P.A.. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K974235. 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 AMPLAID AM50?

AMPLAID AM50 is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Amplifon S.P.A.. The 510(k) number is K974235.

When did AMPLAID AM50 receive FDA 510(k) clearance?

AMPLAID AM50 received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974235.

Who is the listed applicant for AMPLAID AM50?

The FDA 510(k) record lists Amplifon S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLAID AM50?

The FDA product code for AMPLAID AM50 is ETY.

Related Clinical Trials

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Other records listing Amplifon S.P.A. 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.

K992370AMPLAID A724 AND A728K983915AMPLAID A315 AND A319K983712AMPLAID A311 SERIESK971740AMPLAID MK12K972959AMPLAID MK22K972862AMPLAID 171S

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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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