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FDA 510(k)

VOICEWAVE

K-Number: K923924 · 1992-08-24

ApplicantPersonal Sound Technologies, Inc.
Decision Date1992-08-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOICEWAVE is the device name listed in this FDA 510(k) record. The listed applicant is Personal Sound Technologies, Inc.. It received FDA 510(k) clearance on 1992-08-24 under 510(k) number K923924. 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 VOICEWAVE?

VOICEWAVE is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Personal Sound Technologies, Inc.. The 510(k) number is K923924.

When did VOICEWAVE receive FDA 510(k) clearance?

VOICEWAVE received FDA 510(k) clearance on 1992-08-24, under 510(k) number K923924.

Who is the listed applicant for VOICEWAVE?

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

What is the FDA product code for VOICEWAVE?

The FDA product code for VOICEWAVE is ESD.

Related Clinical Trials

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Other records listing Personal Sound Technologies, 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.

K930541VOICEMODE, ITE, AIR-CONDUCTION HEARING AID

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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