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FDA 510(k)

AMPLAID A311 SERIES

K-Number: K983712 · 1999-01-12

ApplicantAmplifon S.P.A.
Decision Date1999-01-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMPLAID A311 SERIES 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 1999-01-12 under 510(k) number K983712. 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 A311 SERIES?

AMPLAID A311 SERIES is a medical device that received FDA 510(k) clearance on 1999-01-12. The listed applicant is Amplifon S.P.A.. The 510(k) number is K983712.

When did AMPLAID A311 SERIES receive FDA 510(k) clearance?

AMPLAID A311 SERIES received FDA 510(k) clearance on 1999-01-12, under 510(k) number K983712.

Who is the listed applicant for AMPLAID A311 SERIES?

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 A311 SERIES?

The FDA product code for AMPLAID A311 SERIES is EWO.

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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 A319K971740AMPLAID MK12K974235AMPLAID AM50K972959AMPLAID MK22K972862AMPLAID 171S

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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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