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FDA 510(k)

IN-THE-EAR MODEL 821

K-Number: K812938 · 1981-11-06

ApplicantDanavox, Inc.
Decision Date1981-11-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN-THE-EAR MODEL 821 is the device name listed in this FDA 510(k) record. The listed applicant is Danavox, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812938. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-THE-EAR MODEL 821?

IN-THE-EAR MODEL 821 is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Danavox, Inc.. The 510(k) number is K812938.

When did IN-THE-EAR MODEL 821 receive FDA 510(k) clearance?

IN-THE-EAR MODEL 821 received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812938.

Who is the listed applicant for IN-THE-EAR MODEL 821?

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

What is the FDA product code for IN-THE-EAR MODEL 821?

The FDA product code for IN-THE-EAR MODEL 821 is ESD.

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Other records listing Danavox, Inc. as applicant

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Related Devices (Code: ESD)

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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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