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FDA 510(k)

PRIZM HEARING SYSTEM

K-Number: K930909 · 1993-08-09

ApplicantAudioscience, Inc.
Decision Date1993-08-09
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PRIZM HEARING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Audioscience, Inc.. It received FDA 510(k) clearance on 1993-08-09 under 510(k) number K930909. 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 PRIZM HEARING SYSTEM?

PRIZM HEARING SYSTEM is a medical device that received FDA 510(k) clearance on 1993-08-09. The listed applicant is Audioscience, Inc.. The 510(k) number is K930909.

When did PRIZM HEARING SYSTEM receive FDA 510(k) clearance?

PRIZM HEARING SYSTEM received FDA 510(k) clearance on 1993-08-09, under 510(k) number K930909.

Who is the listed applicant for PRIZM HEARING SYSTEM?

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 PRIZM HEARING SYSTEM?

The FDA product code for PRIZM HEARING SYSTEM 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 BTEK922422PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPESK902846PRIZM 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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