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FDA 510(k)

PREMIER K-AMP

K-Number: K914799 · 1992-02-18

ApplicantElectone, Inc.
Decision Date1992-02-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PREMIER K-AMP is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K914799. 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 PREMIER K-AMP?

PREMIER K-AMP is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Electone, Inc.. The 510(k) number is K914799.

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

PREMIER K-AMP received FDA 510(k) clearance on 1992-02-18, under 510(k) number K914799.

Who is the listed applicant for PREMIER K-AMP?

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 PREMIER K-AMP?

The FDA product code for PREMIER K-AMP is ESD.

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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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