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FDA 510(k)

K-AMP

K-Number: K934444 · 1993-10-08

ApplicantArgosy Electronics
Decision Date1993-10-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

K-AMP is the device name listed in this FDA 510(k) record. The listed applicant is Argosy Electronics. It received FDA 510(k) clearance on 1993-10-08 under 510(k) number K934444. 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?

K-AMP is a medical device that received FDA 510(k) clearance on 1993-10-08. The listed applicant is Argosy Electronics. The 510(k) number is K934444.

When did K-AMP receive FDA 510(k) clearance?

K-AMP received FDA 510(k) clearance on 1993-10-08, under 510(k) number K934444.

Who is the listed applicant for K-AMP?

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?

The FDA product code for K-AMP is ESD.

Other records listing Argosy Electronics 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.

K974242ARGOSY PROGRAMMABLE ONQUEK971699ARGOSY DYNAMEQK961729ARGOSY PROGRAMMABLEK954038K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENTK952451CLASS D LINEAR WITH ACTIVE TONE CONTROLK952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL

View all 24 devices →

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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