House Infrared/Video Electronystagmograph System
FDA 510(k) K925111 · Eye Dynamics, Inc.
510(k) numberK925111
Submission
- Device name
- House Infrared/Video Electronystagmograph System
- Applicant
- Eye Dynamics, Inc.
Torrance, CA, US - Received
- October 9, 1992
- Decision date
- March 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was House Infrared/Video Electronystagmograph System cleared by the FDA?
House Infrared/Video Electronystagmograph System (K925111) received a 510(k) decision of Substantially Equivalent on March 23, 1994, 530 days after the submission was received.
What is the product code of K925111?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.