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FDA 510(k)

PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES

K-Number: K922422 · 1992-06-10

ApplicantAudioscience, Inc.
Decision Date1992-06-10
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES is the device name listed in this FDA 510(k) record. The listed applicant is Audioscience, Inc.. It received FDA 510(k) clearance on 1992-06-10 under 510(k) number K922422. 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 PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES?

PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Audioscience, Inc.. The 510(k) number is K922422.

When did PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES receive FDA 510(k) clearance?

PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES received FDA 510(k) clearance on 1992-06-10, under 510(k) number K922422.

Who is the listed applicant for PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES?

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

What is the FDA product code for PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES?

The FDA product code for PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES is ESD.

Related Clinical Trials

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.

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Other records listing Audioscience, 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.

K936007PRIZM HEARING SYSTEM, MODEL POWER BTEK930909PRIZM HEARING SYSTEMK902846PRIZM HEARING SYSTEM

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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