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FDA 510(k)

IN-THE-EAR HEARING AID MODEL

K-Number: K833486 · 1984-06-22

ApplicantDanavox, Inc.
Decision Date1984-06-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN-THE-EAR HEARING AID MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Danavox, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K833486. 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 IN-THE-EAR HEARING AID MODEL?

IN-THE-EAR HEARING AID MODEL is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Danavox, Inc.. The 510(k) number is K833486.

When did IN-THE-EAR HEARING AID MODEL receive FDA 510(k) clearance?

IN-THE-EAR HEARING AID MODEL received FDA 510(k) clearance on 1984-06-22, under 510(k) number K833486.

Who is the listed applicant for IN-THE-EAR HEARING AID MODEL?

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

What is the FDA product code for IN-THE-EAR HEARING AID MODEL?

The FDA product code for IN-THE-EAR HEARING AID MODEL is ESD.

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Other records listing Danavox, 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.

K940608155 PP AGC-IK851069BODY TYPE HEARING AID 107SK843791BEHIND-THE-EAR 123 VTHK832326BEHIND-THE-EAR #123 AGCIK832751BEHIND-THE-EAR SERIES 125K823073101M IN-THE-EAR

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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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