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FDA 510(k)

AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID

K-Number: K881653 · 1988-05-13

ApplicantAudiotone, Inc.
Decision Date1988-05-13
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Audiotone, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K881653. 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 AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID?

AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Audiotone, Inc.. The 510(k) number is K881653.

When did AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID receive FDA 510(k) clearance?

AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID received FDA 510(k) clearance on 1988-05-13, under 510(k) number K881653.

Who is the listed applicant for AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID?

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

What is the FDA product code for AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID?

The FDA product code for AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID is ESD.

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Other records listing Audiotone, 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.

K881737AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AIDK881738AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AIDK881652AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AIDK880223MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AIDK880225MAGIC EAR MODEL CI IN-THE-EAR HEARING AIDK880224MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID

View all 12 devices →

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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