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FDA 510(k)

SCREENING AUDIOMETER, HIGH FREQUENCY

K-Number: K790878 · 1979-08-03

ApplicantVicon Instrument Co.
Decision Date1979-08-03
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SCREENING AUDIOMETER, HIGH FREQUENCY is the device name listed in this FDA 510(k) record. The listed applicant is Vicon Instrument Co.. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K790878. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREENING AUDIOMETER, HIGH FREQUENCY?

SCREENING AUDIOMETER, HIGH FREQUENCY is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Vicon Instrument Co.. The 510(k) number is K790878.

When did SCREENING AUDIOMETER, HIGH FREQUENCY receive FDA 510(k) clearance?

SCREENING AUDIOMETER, HIGH FREQUENCY received FDA 510(k) clearance on 1979-08-03, under 510(k) number K790878.

Who is the listed applicant for SCREENING AUDIOMETER, HIGH FREQUENCY?

The FDA 510(k) record lists Vicon Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCREENING AUDIOMETER, HIGH FREQUENCY?

The FDA product code for SCREENING AUDIOMETER, HIGH FREQUENCY is EWO.

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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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