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FDA 510(k)

SHARP II HELIX HEARING AID

K-Number: K941295 · 1994-06-17

ApplicantMiracle-Ear, Inc.
Decision Date1994-06-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SHARP II HELIX HEARING AID 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 1994-06-17 under 510(k) number K941295. 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 SHARP II HELIX HEARING AID?

SHARP II HELIX HEARING AID is a medical device that received FDA 510(k) clearance on 1994-06-17. The listed applicant is Miracle-Ear, Inc.. The 510(k) number is K941295.

When did SHARP II HELIX HEARING AID receive FDA 510(k) clearance?

SHARP II HELIX HEARING AID received FDA 510(k) clearance on 1994-06-17, under 510(k) number K941295.

Who is the listed applicant for SHARP II HELIX HEARING AID?

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 SHARP II HELIX HEARING AID?

The FDA product code for SHARP II HELIX HEARING AID 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.

K972344MIRACLE-EAR DIGITAL BTEK972345DAHLBERG/MIRACLE-EARK972346MIRACLE-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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