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FDA 510(k)

AUDINA

K-Number: K882004 · 1988-06-01

ApplicantAmerican Audio Services, Inc.
Decision Date1988-06-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDINA is the device name listed in this FDA 510(k) record. The listed applicant is American Audio Services, Inc.. It received FDA 510(k) clearance on 1988-06-01 under 510(k) number K882004. 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 AUDINA?

AUDINA is a medical device that received FDA 510(k) clearance on 1988-06-01. The listed applicant is American Audio Services, Inc.. The 510(k) number is K882004.

When did AUDINA receive FDA 510(k) clearance?

AUDINA received FDA 510(k) clearance on 1988-06-01, under 510(k) number K882004.

Who is the listed applicant for AUDINA?

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

What is the FDA product code for AUDINA?

The FDA product code for AUDINA 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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