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FDA 510(k)

WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL

K-Number: K901317 · 1990-04-10

ApplicantWidex Hearing Aid Co., Inc.
Decision Date1990-04-10
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL 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 1990-04-10 under 510(k) number K901317. 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 WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL?

WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL is a medical device that received FDA 510(k) clearance on 1990-04-10. The listed applicant is Widex Hearing Aid Co., Inc.. The 510(k) number is K901317.

When did WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL receive FDA 510(k) clearance?

WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL received FDA 510(k) clearance on 1990-04-10, under 510(k) number K901317.

Who is the listed applicant for WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL?

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 WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL?

The FDA product code for WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL is ESD.

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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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