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FDA 510(k)

DANAVOX MODEL CIC

K-Number: K942331 · 1994-11-15

ApplicantGn Danavox, Inc.
Decision Date1994-11-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DANAVOX MODEL CIC 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 1994-11-15 under 510(k) number K942331. 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 DANAVOX MODEL CIC?

DANAVOX MODEL CIC is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is Gn Danavox, Inc.. The 510(k) number is K942331.

When did DANAVOX MODEL CIC receive FDA 510(k) clearance?

DANAVOX MODEL CIC received FDA 510(k) clearance on 1994-11-15, under 510(k) number K942331.

Who is the listed applicant for DANAVOX MODEL CIC?

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 DANAVOX MODEL CIC?

The FDA product code for DANAVOX MODEL CIC is ESD.

Related Clinical Trials

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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 BTEK924185DFS GENIUS BTEK905692143 SERIES BTEK905679133 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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