Nystagram Video Nystagmography System
FDA 510(k) K130201 · Ototronix, LLC
510(k) numberK130201
Submission
- Device name
- Nystagram Video Nystagmography System
- Applicant
- Ototronix, LLC
St. Paul, MN, US - Received
- January 28, 2013
- Decision date
- April 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Nystagram Video Nystagmography System cleared by the FDA?
Nystagram Video Nystagmography System (K130201) received a 510(k) decision of Substantially Equivalent on April 26, 2013, 88 days after the submission was received.
What is the product code of K130201?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.