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FDA 510(k)

LX-ITC

K-Number: K946071 · 1995-01-30

ApplicantWidex Hearing Aid Co., Inc.
Decision Date1995-01-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LX-ITC is the device name listed in this FDA 510(k) record. The listed applicant is Widex Hearing Aid Co., Inc.. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K946071. 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 LX-ITC?

LX-ITC is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Widex Hearing Aid Co., Inc.. The 510(k) number is K946071.

When did LX-ITC receive FDA 510(k) clearance?

LX-ITC received FDA 510(k) clearance on 1995-01-30, under 510(k) number K946071.

Who is the listed applicant for LX-ITC?

The FDA 510(k) record lists Widex Hearing Aid Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LX-ITC?

The FDA product code for LX-ITC is ESD.

Other records listing Widex Hearing Aid Co., 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.

K080955ZEN PROGRAM (MIND 440 HEARING AID)K971535WIDEX SENSO DIGITAL (MINI CANAL)K970904WIDEX SENSO DIGITAL (CIC)K965254WIDEX MODEL SENSO DIGITAL (C9)K965218SENSO DIGITAL (C18)K955879WIDEX MODEL SENSO DIGITAL (C16)

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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

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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