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FDA 510(k)

AUDIOTONE (A-552)

K-Number: K965063 · 1997-01-27

ApplicantMiracle-Ear, Inc.
Decision Date1997-01-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOTONE (A-552) is the device name listed in this FDA 510(k) record. The listed applicant is Miracle-Ear, Inc.. It received FDA 510(k) clearance on 1997-01-27 under 510(k) number K965063. 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 (A-552)?

AUDIOTONE (A-552) is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Miracle-Ear, Inc.. The 510(k) number is K965063.

When did AUDIOTONE (A-552) receive FDA 510(k) clearance?

AUDIOTONE (A-552) received FDA 510(k) clearance on 1997-01-27, under 510(k) number K965063.

Who is the listed applicant for AUDIOTONE (A-552)?

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

What is the FDA product code for AUDIOTONE (A-552)?

The FDA product code for AUDIOTONE (A-552) is ESD.

Related Clinical Trials

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Other records listing Miracle-Ear, 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.

K972346MIRACLE-EAR ITE DIGITALK972344MIRACLE-EAR DIGITAL BTEK972345DAHLBERG/MIRACLE-EARK970262MULTI-CHANNEL COMPRESSION BTE (SD)K964419MIRACLE - EAR (ITE/ITC/CIC)K965049DAHLBERG (A-554)

View all 65 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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