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FDA 510(k)

SIEMENS BTE HEARING AIDS

K-Number: K942857 · 1994-08-22

ApplicantSiemens Hearing Instruments, Inc.
Decision Date1994-08-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SIEMENS BTE HEARING AIDS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1994-08-22 under 510(k) number K942857. 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 SIEMENS BTE HEARING AIDS?

SIEMENS BTE HEARING AIDS is a medical device that received FDA 510(k) clearance on 1994-08-22. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K942857.

When did SIEMENS BTE HEARING AIDS receive FDA 510(k) clearance?

SIEMENS BTE HEARING AIDS received FDA 510(k) clearance on 1994-08-22, under 510(k) number K942857.

Who is the listed applicant for SIEMENS BTE HEARING AIDS?

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

What is the FDA product code for SIEMENS BTE HEARING AIDS?

The FDA product code for SIEMENS BTE HEARING AIDS is ESD.

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Other records listing Siemens Hearing Instruments, 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.

K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)K011364CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K003559TCI (TINNITUS CONTROL INSTRUMENT)K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K972998PRISMA

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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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