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FDA 510(k)

DIGITAL AUDIOMETER/HEARING AID 3100

K-Number: K833883 · 1984-02-21

ApplicantFrye Electronics, Inc.
Decision Date1984-02-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DIGITAL AUDIOMETER/HEARING AID 3100 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 1984-02-21 under 510(k) number K833883. 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 DIGITAL AUDIOMETER/HEARING AID 3100?

DIGITAL AUDIOMETER/HEARING AID 3100 is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Frye Electronics, Inc.. The 510(k) number is K833883.

When did DIGITAL AUDIOMETER/HEARING AID 3100 receive FDA 510(k) clearance?

DIGITAL AUDIOMETER/HEARING AID 3100 received FDA 510(k) clearance on 1984-02-21, under 510(k) number K833883.

Who is the listed applicant for DIGITAL AUDIOMETER/HEARING AID 3100?

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 DIGITAL AUDIOMETER/HEARING AID 3100?

The FDA product code for DIGITAL AUDIOMETER/HEARING AID 3100 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.

K123701HEARLAB ACAK093006FONIX ,MODEL 8000K022510FONIX, MODEL 7000K980377FONIX FP35 HEARING AID ANALYZERK935400FONIX 3500 HEARING AID ANALYZERK913221TYPE FA10 AUDIOMETER

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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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