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FDA 510(k)

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE

K-Number: K897154 · 1990-04-30

ApplicantNicolet Instrument Corp.
Decision Date1990-04-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Instrument Corp.. It received FDA 510(k) clearance on 1990-04-30 under 510(k) number K897154. 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 NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE?

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE is a medical device that received FDA 510(k) clearance on 1990-04-30. The listed applicant is Nicolet Instrument Corp.. The 510(k) number is K897154.

When did NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE receive FDA 510(k) clearance?

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE received FDA 510(k) clearance on 1990-04-30, under 510(k) number K897154.

Who is the listed applicant for NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE?

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

What is the FDA product code for NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE?

The FDA product code for NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE is ESD.

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Other records listing Nicolet Instrument Corp. 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.

K921138NICOLET ULTRASOM ACQUISITION STATIONK923315NICOLET ARK SYSTEMK921927NICOLET VOYAGEURK915652NICOLET PORATBLE SPIRIT SYSTEMK905632NICOLET MAPLELEAF SYSTEMK894629NICOLET BEAM II SYSTEM

View all 13 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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