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FDA 510(k)

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

K-Number: K111618 · 2011-12-28

ApplicantNatus Medical Incorporated
Decision Date2011-12-28
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated. It received FDA 510(k) clearance on 2011-12-28 under 510(k) number K111618. 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 AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION?

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION is a medical device that received FDA 510(k) clearance on 2011-12-28. The listed applicant is Natus Medical Incorporated. The 510(k) number is K111618.

When did AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION receive FDA 510(k) clearance?

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION received FDA 510(k) clearance on 2011-12-28, under 510(k) number K111618.

Who is the listed applicant for AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION?

The FDA 510(k) record lists Natus Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION?

The FDA product code for AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION 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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