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FDA 510(k)

AUDITORY STIMULATOR

K-Number: K813557 · 1982-01-19

ApplicantWestern Advanced Technology, Inc.
Decision Date1982-01-19
Product CodeETS
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDITORY STIMULATOR 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 1982-01-19 under 510(k) number K813557. The device is classified under product code ETS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDITORY STIMULATOR?

AUDITORY STIMULATOR is a medical device that received FDA 510(k) clearance on 1982-01-19. The listed applicant is Western Advanced Technology, Inc.. The 510(k) number is K813557.

When did AUDITORY STIMULATOR receive FDA 510(k) clearance?

AUDITORY STIMULATOR received FDA 510(k) clearance on 1982-01-19, under 510(k) number K813557.

Who is the listed applicant for AUDITORY STIMULATOR?

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 AUDITORY STIMULATOR?

The FDA product code for AUDITORY STIMULATOR is ETS.

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 #F1K812138TENS DEVICEK811790OCTOTOXIC SCREENERK811772AUDITORY LOCALIZERK802324E1 SERIES HEARING AID

Related Devices (Code: ETS)

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.

K811790OCTOTOXIC SCREENERWestern Advanced Technology, Inc.K811772AUDITORY LOCALIZERWestern Advanced Technology, Inc.K790064TINNITUS DEVICESVicon Instrument Co.K771188REVERSING CLICK GENERATOR RCG6Teca, 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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