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FDA 510(k)

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM

K-Number: K130201 · 2013-04-26

ApplicantOtotronix, LLC
Decision Date2013-04-26
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ototronix, LLC. It received FDA 510(k) clearance on 2013-04-26 under 510(k) number K130201. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM?

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Ototronix, LLC. The 510(k) number is K130201.

When did NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM receive FDA 510(k) clearance?

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM received FDA 510(k) clearance on 2013-04-26, under 510(k) number K130201.

Who is the listed applicant for NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM?

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

What is the FDA product code for NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM?

The FDA product code for NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM is GWN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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