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FDA 510(k)

ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID

K-Number: K882633 · 1989-01-13

ApplicantEnsoniq Corp.
Decision Date1989-01-13
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID is the device name listed in this FDA 510(k) record. The listed applicant is Ensoniq Corp.. It received FDA 510(k) clearance on 1989-01-13 under 510(k) number K882633. 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 ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID?

ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Ensoniq Corp.. The 510(k) number is K882633.

When did ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID receive FDA 510(k) clearance?

ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID received FDA 510(k) clearance on 1989-01-13, under 510(k) number K882633.

Who is the listed applicant for ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID?

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

What is the FDA product code for ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID?

The FDA product code for ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID is ESD.

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Other records listing Ensoniq 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.

K933097SOUND SELECTOR FULL-SERVICE AUDIOMETER

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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