Electronystagmograph (Eng Recorder)
FDA 510(k) K850180 · Bio-Logic Systems Corp.
510(k) numberK850180
Submission
- Device name
- Electronystagmograph (Eng Recorder)
- Applicant
- Bio-Logic Systems Corp.
Northbrook, IL, US - Received
- January 17, 1985
- Decision date
- July 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Electronystagmograph (Eng Recorder) cleared by the FDA?
Electronystagmograph (Eng Recorder) (K850180) received a 510(k) decision of Substantially Equivalent on July 22, 1985, 186 days after the submission was received.
What is the product code of K850180?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.