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FDA 510(k)

PERSONAL AMPLIFIER MODEL ULTRA HELIX

K-Number: K893433 · 1989-06-14

ApplicantElectone, Inc.
Decision Date1989-06-14
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PERSONAL AMPLIFIER MODEL ULTRA HELIX is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1989-06-14 under 510(k) number K893433. 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 PERSONAL AMPLIFIER MODEL ULTRA HELIX?

PERSONAL AMPLIFIER MODEL ULTRA HELIX is a medical device that received FDA 510(k) clearance on 1989-06-14. The listed applicant is Electone, Inc.. The 510(k) number is K893433.

When did PERSONAL AMPLIFIER MODEL ULTRA HELIX receive FDA 510(k) clearance?

PERSONAL AMPLIFIER MODEL ULTRA HELIX received FDA 510(k) clearance on 1989-06-14, under 510(k) number K893433.

Who is the listed applicant for PERSONAL AMPLIFIER MODEL ULTRA HELIX?

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

What is the FDA product code for PERSONAL AMPLIFIER MODEL ULTRA HELIX?

The FDA product code for PERSONAL AMPLIFIER MODEL ULTRA HELIX is ESD.

Related Clinical Trials

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Other records listing Electone, 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.

K973266Z DEQ-IIK961084AM 400K955702SONATA U-01K953050Z33K953047Z20K953051Z35

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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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