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FDA 510(k)

IN THE EAR MODEL X-ITE 84

K-Number: K844985 · 1985-01-23

ApplicantBernafon, Inc.
Decision Date1985-01-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN THE EAR MODEL X-ITE 84 is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon, Inc.. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844985. 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 X-ITE 84?

IN THE EAR MODEL X-ITE 84 is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Bernafon, Inc.. The 510(k) number is K844985.

When did IN THE EAR MODEL X-ITE 84 receive FDA 510(k) clearance?

IN THE EAR MODEL X-ITE 84 received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844985.

Who is the listed applicant for IN THE EAR MODEL X-ITE 84?

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

What is the FDA product code for IN THE EAR MODEL X-ITE 84?

The FDA product code for IN THE EAR MODEL X-ITE 84 is ESD.

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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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