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FDA 510(k)

VOICEMODE, ITE, AIR-CONDUCTION HEARING AID

K-Number: K930541 · 1993-03-03

ApplicantPersonal Sound Technologies, Inc.
Decision Date1993-03-03
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOICEMODE, ITE, AIR-CONDUCTION HEARING AID 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 1993-03-03 under 510(k) number K930541. 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 VOICEMODE, ITE, AIR-CONDUCTION HEARING AID?

VOICEMODE, ITE, AIR-CONDUCTION HEARING AID is a medical device that received FDA 510(k) clearance on 1993-03-03. The listed applicant is Personal Sound Technologies, Inc.. The 510(k) number is K930541.

When did VOICEMODE, ITE, AIR-CONDUCTION HEARING AID receive FDA 510(k) clearance?

VOICEMODE, ITE, AIR-CONDUCTION HEARING AID received FDA 510(k) clearance on 1993-03-03, under 510(k) number K930541.

Who is the listed applicant for VOICEMODE, ITE, AIR-CONDUCTION HEARING AID?

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 VOICEMODE, ITE, AIR-CONDUCTION HEARING AID?

The FDA product code for VOICEMODE, ITE, AIR-CONDUCTION HEARING AID is ESD.

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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.

K923924VOICEWAVE

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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