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FDA 510(k)

OCTOTOXIC SCREENER

K-Number: K811790 · 1981-07-15

ApplicantWestern Advanced Technology, Inc.
Decision Date1981-07-15
Product CodeETS
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OCTOTOXIC SCREENER 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 1981-07-15 under 510(k) number K811790. 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 OCTOTOXIC SCREENER?

OCTOTOXIC SCREENER is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Western Advanced Technology, Inc.. The 510(k) number is K811790.

When did OCTOTOXIC SCREENER receive FDA 510(k) clearance?

OCTOTOXIC SCREENER received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811790.

Who is the listed applicant for OCTOTOXIC SCREENER?

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 OCTOTOXIC SCREENER?

The FDA product code for OCTOTOXIC SCREENER is ETS.

Related Clinical Trials

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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 DEVICEK811772AUDITORY 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.

K813557AUDITORY STIMULATORWestern 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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