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FDA 510(k)

ACTIVE MODEL AHX HELIX ITE HEARING AID

K-Number: K910705 · 1991-02-28

ApplicantActive Electronics, Inc.
Decision Date1991-02-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACTIVE MODEL AHX HELIX ITE HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Active Electronics, Inc.. It received FDA 510(k) clearance on 1991-02-28 under 510(k) number K910705. 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 ACTIVE MODEL AHX HELIX ITE HEARING AID?

ACTIVE MODEL AHX HELIX ITE HEARING AID is a medical device that received FDA 510(k) clearance on 1991-02-28. The listed applicant is Active Electronics, Inc.. The 510(k) number is K910705.

When did ACTIVE MODEL AHX HELIX ITE HEARING AID receive FDA 510(k) clearance?

ACTIVE MODEL AHX HELIX ITE HEARING AID received FDA 510(k) clearance on 1991-02-28, under 510(k) number K910705.

Who is the listed applicant for ACTIVE MODEL AHX HELIX ITE HEARING AID?

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

What is the FDA product code for ACTIVE MODEL AHX HELIX ITE HEARING AID?

The FDA product code for ACTIVE MODEL AHX HELIX ITE HEARING AID is ESD.

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Other records listing Active Electronics, 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.

K945218ACTIVE MODEL CICK910704ACTIVE MODEL AMC MINI CANAL ITE HEARING AIDK910703ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AIDK910702ACTIVE MODEL AHS HALF SHELL ITE HEARING AIDK910701ACTIVE MODEL ALP LOW PROFILE ITE HEARING AIDK910700ACTIVE MODEL AST CUSTOM ITE HEARING AID

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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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