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FDA 510(k)

NICOLET DIGITAL TWO PIECE HEARING AID

K-Number: K873736 · 1987-12-08

ApplicantNicolet Biomedical Instruments
Decision Date1987-12-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NICOLET DIGITAL TWO PIECE HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1987-12-08 under 510(k) number K873736. 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 DIGITAL TWO PIECE HEARING AID?

NICOLET DIGITAL TWO PIECE HEARING AID is a medical device that received FDA 510(k) clearance on 1987-12-08. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K873736.

When did NICOLET DIGITAL TWO PIECE HEARING AID receive FDA 510(k) clearance?

NICOLET DIGITAL TWO PIECE HEARING AID received FDA 510(k) clearance on 1987-12-08, under 510(k) number K873736.

Who is the listed applicant for NICOLET DIGITAL TWO PIECE HEARING AID?

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

What is the FDA product code for NICOLET DIGITAL TWO PIECE HEARING AID?

The FDA product code for NICOLET DIGITAL TWO PIECE HEARING AID is ESD.

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Other records listing Nicolet Biomedical Instruments 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.

K880573MODIFIED NICOLET VIKING SYSTEMK873964NICOLET DISPOSABLE PRASS PROBEK873535NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEMK871678NICOLET AMP 6R11 SYSTEMK862592PHOENIX SYSTEM SEVEN.K851190NYSTAGMOGRAPH EOG/ENG ANALYSES

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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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