Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200A
FDA 510(k) K080546 · Nihon Kohden America, Inc.
510(k) numberK080546
Submission
- Device name
- Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200A
- Applicant
- Nihon Kohden America, Inc.
Foothill, CA, US - Received
- February 28, 2008
- Decision date
- August 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLT – Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
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Questions and answers
When was Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200A cleared by the FDA?
Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200A (K080546) received a 510(k) decision of Substantially Equivalent on August 29, 2008, 183 days after the submission was received.
What is the product code of K080546?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.