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FDA 510(k)

CUSTOM IN-THE-EAR

K-Number: K863975 · 1986-11-07

ApplicantGn Danavox, Inc.
Decision Date1986-11-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM IN-THE-EAR is the device name listed in this FDA 510(k) record. The listed applicant is Gn Danavox, Inc.. It received FDA 510(k) clearance on 1986-11-07 under 510(k) number K863975. 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 CUSTOM IN-THE-EAR?

CUSTOM IN-THE-EAR is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is Gn Danavox, Inc.. The 510(k) number is K863975.

When did CUSTOM IN-THE-EAR receive FDA 510(k) clearance?

CUSTOM IN-THE-EAR received FDA 510(k) clearance on 1986-11-07, under 510(k) number K863975.

Who is the listed applicant for CUSTOM IN-THE-EAR?

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

What is the FDA product code for CUSTOM IN-THE-EAR?

The FDA product code for CUSTOM IN-THE-EAR is ESD.

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Other records listing Gn 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.

K971032DANAVOX MODELS 163/162 BTEK971031AUDALLION III HEARING SYSTEMK942331DANAVOX MODEL CICK924185DFS GENIUS BTEK905679133 SERIES BTEK905692143 SERIES BTE

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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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