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FDA 510(k)

TYPE FA10 AUDIOMETER

K-Number: K913221 · 1991-10-11

ApplicantFrye Electronics, Inc.
Decision Date1991-10-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYPE FA10 AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Frye Electronics, Inc.. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K913221. 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 TYPE FA10 AUDIOMETER?

TYPE FA10 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Frye Electronics, Inc.. The 510(k) number is K913221.

When did TYPE FA10 AUDIOMETER receive FDA 510(k) clearance?

TYPE FA10 AUDIOMETER received FDA 510(k) clearance on 1991-10-11, under 510(k) number K913221.

Who is the listed applicant for TYPE FA10 AUDIOMETER?

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

What is the FDA product code for TYPE FA10 AUDIOMETER?

The FDA product code for TYPE FA10 AUDIOMETER is EWO.

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Other records listing Frye Electronics, 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.

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Related Devices (Code: 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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