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FDA 510(k)

MIRACLE EAR AND AUDIOTONE

K-Number: K954941 · 1995-12-22

ApplicantMiracle-Ear, Inc.
Decision Date1995-12-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MIRACLE EAR AND AUDIOTONE 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 1995-12-22 under 510(k) number K954941. 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 MIRACLE EAR AND AUDIOTONE?

MIRACLE EAR AND AUDIOTONE is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Miracle-Ear, Inc.. The 510(k) number is K954941.

When did MIRACLE EAR AND AUDIOTONE receive FDA 510(k) clearance?

MIRACLE EAR AND AUDIOTONE received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954941.

Who is the listed applicant for MIRACLE EAR AND AUDIOTONE?

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 MIRACLE EAR AND AUDIOTONE?

The FDA product code for MIRACLE EAR AND AUDIOTONE is ESD.

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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.

K972345DAHLBERG/MIRACLE-EARK972344MIRACLE-EAR DIGITAL BTEK972346MIRACLE-EAR ITE DIGITALK970262MULTI-CHANNEL COMPRESSION BTE (SD)K964419MIRACLE - EAR (ITE/ITC/CIC)K965049DAHLBERG (A-554)

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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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