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FDA 510(k)

E1 SERIES HEARING AID

K-Number: K802324 · 1980-10-10

ApplicantWestern Advanced Technology, Inc.
Decision Date1980-10-10
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

E1 SERIES HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Western Advanced Technology, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802324. 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 E1 SERIES HEARING AID?

E1 SERIES HEARING AID is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Western Advanced Technology, Inc.. The 510(k) number is K802324.

When did E1 SERIES HEARING AID receive FDA 510(k) clearance?

E1 SERIES HEARING AID received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802324.

Who is the listed applicant for E1 SERIES HEARING AID?

The FDA 510(k) record lists Western Advanced Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E1 SERIES HEARING AID?

The FDA product code for E1 SERIES HEARING AID 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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Other records listing Western Advanced Technology, 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.

K822411SYSTEM 80 FACEPLATE-IN-THE-EAR #F1K813557AUDITORY STIMULATORK812138TENS DEVICEK811790OCTOTOXIC SCREENERK811772AUDITORY LOCALIZER

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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