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FDA 510(k)

A BAER WITH ABAER I/O FUNCTION

K-Number: K112247 · 2012-04-02

ApplicantNatus Medical Incorporated
Decision Date2012-04-02
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

A BAER WITH ABAER 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 2012-04-02 under 510(k) number K112247. 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 A BAER WITH ABAER I/O FUNCTION?

A BAER WITH ABAER I/O FUNCTION is a medical device that received FDA 510(k) clearance on 2012-04-02. The listed applicant is Natus Medical Incorporated. The 510(k) number is K112247.

When did A BAER WITH ABAER I/O FUNCTION receive FDA 510(k) clearance?

A BAER WITH ABAER I/O FUNCTION received FDA 510(k) clearance on 2012-04-02, under 510(k) number K112247.

Who is the listed applicant for A BAER WITH ABAER 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 A BAER WITH ABAER I/O FUNCTION?

The FDA product code for A BAER WITH ABAER 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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