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FDA 510(k)

K-BASS LO FREQUENCY HEARING AID

K-Number: K843144 · 1984-09-07

ApplicantEtymotic Research
Decision Date1984-09-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

K-BASS LO FREQUENCY HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Etymotic Research. It received FDA 510(k) clearance on 1984-09-07 under 510(k) number K843144. 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-BASS LO FREQUENCY HEARING AID?

K-BASS LO FREQUENCY HEARING AID is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Etymotic Research. The 510(k) number is K843144.

When did K-BASS LO FREQUENCY HEARING AID receive FDA 510(k) clearance?

K-BASS LO FREQUENCY HEARING AID received FDA 510(k) clearance on 1984-09-07, under 510(k) number K843144.

Who is the listed applicant for K-BASS LO FREQUENCY HEARING AID?

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

What is the FDA product code for K-BASS LO FREQUENCY HEARING AID?

The FDA product code for K-BASS LO FREQUENCY HEARING AID is ESD.

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Other records listing Etymotic Research 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.

K011114ETYMOTIC RESEARCH ER-10D OAE PROBEK010165ERO SCAN OAE TEST SYSTEMK980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTK930003TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONESK873298ELEC-TIP

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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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