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FDA 510(k)

133 SERIES BTE

K-Number: K905679 · 1991-01-28

ApplicantGn Danavox, Inc.
Decision Date1991-01-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

133 SERIES BTE 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 1991-01-28 under 510(k) number K905679. 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 133 SERIES BTE?

133 SERIES BTE is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is Gn Danavox, Inc.. The 510(k) number is K905679.

When did 133 SERIES BTE receive FDA 510(k) clearance?

133 SERIES BTE received FDA 510(k) clearance on 1991-01-28, under 510(k) number K905679.

Who is the listed applicant for 133 SERIES BTE?

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 133 SERIES BTE?

The FDA product code for 133 SERIES BTE 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.

K971031AUDALLION III HEARING SYSTEMK971032DANAVOX MODELS 163/162 BTEK942331DANAVOX MODEL CICK924185DFS GENIUS BTEK905692143 SERIES BTEK896996CAS (COMPUTERIZED ANALYZER SYSTEM)

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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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