Ote Biomedica Neurograph 9
FDA 510(k) K820604 · Del Mar Avionics
510(k) numberK820604
Submission
- Device name
- Ote Biomedica Neurograph 9
- Applicant
- Del Mar Avionics
Walker, MI, US - Received
- March 5, 1982
- Decision date
- March 23, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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Questions and answers
When was Ote Biomedica Neurograph 9 cleared by the FDA?
Ote Biomedica Neurograph 9 (K820604) received a 510(k) decision of Substantially Equivalent on March 23, 1982, 18 days after the submission was received.
What is the product code of K820604?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.