FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTE BIOMEDICA BERG FOURIER ANALYZER
K Number: K820653
·
Decision May 7, 1982
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
51
Applicant Total
54
Review Days
59
Basic Information
- Device Name
- OTE BIOMEDICA BERG FOURIER ANALYZER
- K Number
- K820653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- DEL MAR AVIONICS
- Date Received
- March 9, 1982
- Decision Date
- May 7, 1982
- Product Code
- OLT
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | FDA class 2 | Neurology |
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