Ote Biomedica Berg Fourier Analyzer
FDA 510(k) K820653 · Del Mar Avionics
510(k) numberK820653
Submission
- Device name
- Ote Biomedica Berg Fourier Analyzer
- Applicant
- Del Mar Avionics
Mchenry, IL, US - Received
- March 9, 1982
- Decision date
- May 7, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Ote Biomedica Berg Fourier Analyzer cleared by the FDA?
Ote Biomedica Berg Fourier Analyzer (K820653) received a 510(k) decision of Substantially Equivalent on May 7, 1982, 59 days after the submission was received.
What is the product code of K820653?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.