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FDA 510(k)

HEARING AID CUSTOM ITE

K-Number: K813206 · 1981-12-08

ApplicantDuvan Acoustics, Inc.
Decision Date1981-12-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID CUSTOM ITE is the device name listed in this FDA 510(k) record. The listed applicant is Duvan Acoustics, Inc.. It received FDA 510(k) clearance on 1981-12-08 under 510(k) number K813206. 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 HEARING AID CUSTOM ITE?

HEARING AID CUSTOM ITE is a medical device that received FDA 510(k) clearance on 1981-12-08. The listed applicant is Duvan Acoustics, Inc.. The 510(k) number is K813206.

When did HEARING AID CUSTOM ITE receive FDA 510(k) clearance?

HEARING AID CUSTOM ITE received FDA 510(k) clearance on 1981-12-08, under 510(k) number K813206.

Who is the listed applicant for HEARING AID CUSTOM ITE?

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

What is the FDA product code for HEARING AID CUSTOM ITE?

The FDA product code for HEARING AID CUSTOM ITE 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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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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