Video Eye Trakker
FDA 510(k) K964646 · Micromedical Technologies, Inc.
510(k) numberK964646
Submission
- Device name
- Video Eye Trakker
- Applicant
- Micromedical Technologies, Inc.
Chatham, IL, US - Received
- November 20, 1996
- Decision date
- July 15, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K964325 | Visualeyes: Video Eye MonitorGWN · Traditional | 07/15/1997SE |
| K922037 | System 2000, Rotational Vestibular ChairLXV · Traditional | 10/26/1992SE |
| K891008 | Vestibular Ocular Reflex Test Equipment(Vorteq)LXV · Traditional | 05/31/1989SE |
| K863424 | Computer Eye Tracking Sys./Eng Exam. Chair & TableGWN · Traditional | 03/23/1987SE |
Questions and answers
When was Video Eye Trakker cleared by the FDA?
Video Eye Trakker (K964646) received a 510(k) decision of Substantially Equivalent on July 15, 1997, 237 days after the submission was received.
What is the product code of K964646?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.