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FDA 510(k)

EXTEND-EAR

K-Number: K920466 · 1992-02-27

ApplicantSonovation, Inc. Dba Avr Sonovation
Decision Date1992-02-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EXTEND-EAR is the device name listed in this FDA 510(k) record. The listed applicant is Sonovation, Inc. Dba Avr Sonovation. It received FDA 510(k) clearance on 1992-02-27 under 510(k) number K920466. 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 EXTEND-EAR?

EXTEND-EAR is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Sonovation, Inc. Dba Avr Sonovation. The 510(k) number is K920466.

When did EXTEND-EAR receive FDA 510(k) clearance?

EXTEND-EAR received FDA 510(k) clearance on 1992-02-27, under 510(k) number K920466.

Who is the listed applicant for EXTEND-EAR?

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

What is the FDA product code for EXTEND-EAR?

The FDA product code for EXTEND-EAR is ESD.

Related Clinical Trials

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.

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Other records listing Sonovation, Inc. Dba Avr Sonovation 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.

K905516MODEL FT40 TRANSONIC(TM) HEARING AID

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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