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FDA 510(k)

BEHIND-THE-EAR HEARING AID MODEL 408 W-H

K-Number: K891251 · 1989-03-31

ApplicantSiemens Hearing Instruments, Inc.
Decision Date1989-03-31
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND-THE-EAR HEARING AID MODEL 408 W-H 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 1989-03-31 under 510(k) number K891251. 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 BEHIND-THE-EAR HEARING AID MODEL 408 W-H?

BEHIND-THE-EAR HEARING AID MODEL 408 W-H is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K891251.

When did BEHIND-THE-EAR HEARING AID MODEL 408 W-H receive FDA 510(k) clearance?

BEHIND-THE-EAR HEARING AID MODEL 408 W-H received FDA 510(k) clearance on 1989-03-31, under 510(k) number K891251.

Who is the listed applicant for BEHIND-THE-EAR HEARING AID MODEL 408 W-H?

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 BEHIND-THE-EAR HEARING AID MODEL 408 W-H?

The FDA product code for BEHIND-THE-EAR HEARING AID MODEL 408 W-H 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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