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FDA 510(k)

AMPLAID 460

K-Number: K971747 · 1997-08-05

ApplicantAmplifon S.P.A.
Decision Date1997-08-05
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMPLAID 460 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 1997-08-05 under 510(k) number K971747. 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 AMPLAID 460?

AMPLAID 460 is a medical device that received FDA 510(k) clearance on 1997-08-05. The listed applicant is Amplifon S.P.A.. The 510(k) number is K971747.

When did AMPLAID 460 receive FDA 510(k) clearance?

AMPLAID 460 received FDA 510(k) clearance on 1997-08-05, under 510(k) number K971747.

Who is the listed applicant for AMPLAID 460?

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 460?

The FDA product code for AMPLAID 460 is EWO.

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 MK12K974235AMPLAID AM50K972959AMPLAID MK22

View all 8 devices →

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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