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FDA 510(k)

EURION LOTOS PP HEARING AID

K-Number: K923226 · 1992-07-30

ApplicantEurion Hearing Instruments
Decision Date1992-07-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EURION LOTOS PP HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Eurion Hearing Instruments. It received FDA 510(k) clearance on 1992-07-30 under 510(k) number K923226. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EURION LOTOS PP HEARING AID?

EURION LOTOS PP HEARING AID is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Eurion Hearing Instruments. The 510(k) number is K923226.

When did EURION LOTOS PP HEARING AID receive FDA 510(k) clearance?

EURION LOTOS PP HEARING AID received FDA 510(k) clearance on 1992-07-30, under 510(k) number K923226.

Who is the listed applicant for EURION LOTOS PP HEARING AID?

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

What is the FDA product code for EURION LOTOS PP HEARING AID?

The FDA product code for EURION LOTOS PP HEARING AID is ESD.

Related Clinical Trials

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Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

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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