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FDA 510(k)

AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC

K-Number: K895517 · 1990-01-04

ApplicantAural Technologies, Inc.
Decision Date1990-01-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC is the device name listed in this FDA 510(k) record. The listed applicant is Aural Technologies, Inc.. It received FDA 510(k) clearance on 1990-01-04 under 510(k) number K895517. 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 AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC?

AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC is a medical device that received FDA 510(k) clearance on 1990-01-04. The listed applicant is Aural Technologies, Inc.. The 510(k) number is K895517.

When did AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC receive FDA 510(k) clearance?

AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC received FDA 510(k) clearance on 1990-01-04, under 510(k) number K895517.

Who is the listed applicant for AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC?

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

What is the FDA product code for AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC?

The FDA product code for AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC is ESD.

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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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