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FDA 510(k)

COAST HEARING CHS (CUSTOM HEARING SYSTEM)

K-Number: K954937 · 1995-11-13

ApplicantCoast Hearing Services
Decision Date1995-11-13
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COAST HEARING CHS (CUSTOM HEARING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Coast Hearing Services. It received FDA 510(k) clearance on 1995-11-13 under 510(k) number K954937. 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 COAST HEARING CHS (CUSTOM HEARING SYSTEM)?

COAST HEARING CHS (CUSTOM HEARING SYSTEM) is a medical device that received FDA 510(k) clearance on 1995-11-13. The listed applicant is Coast Hearing Services. The 510(k) number is K954937.

When did COAST HEARING CHS (CUSTOM HEARING SYSTEM) receive FDA 510(k) clearance?

COAST HEARING CHS (CUSTOM HEARING SYSTEM) received FDA 510(k) clearance on 1995-11-13, under 510(k) number K954937.

Who is the listed applicant for COAST HEARING CHS (CUSTOM HEARING SYSTEM)?

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

What is the FDA product code for COAST HEARING CHS (CUSTOM HEARING SYSTEM)?

The FDA product code for COAST HEARING CHS (CUSTOM HEARING SYSTEM) is ESD.

Related Clinical Trials

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.

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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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