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FDA 510(k)

K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT

K-Number: K954038 · 1995-09-18

ApplicantArgosy Electronics
Decision Date1995-09-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Argosy Electronics. It received FDA 510(k) clearance on 1995-09-18 under 510(k) number K954038. 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 K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT?

K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Argosy Electronics. The 510(k) number is K954038.

When did K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT receive FDA 510(k) clearance?

K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT received FDA 510(k) clearance on 1995-09-18, under 510(k) number K954038.

Who is the listed applicant for K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT?

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

What is the FDA product code for K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT?

The FDA product code for K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT is ESD.

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Other records listing Argosy Electronics as applicant

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K974242ARGOSY PROGRAMMABLE ONQUEK971699ARGOSY DYNAMEQK961729ARGOSY PROGRAMMABLEK952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROLK952452OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROLK952451CLASS D LINEAR WITH ACTIVE TONE CONTROL

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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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