FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
QUANTIMAP III
K Number: K863650
·
Decision Sep 26, 1986
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
53
Applicant Total
3
Review Days
8
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Basic Information
- Device Name
- QUANTIMAP III
- K Number
- K863650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Quantified Signal Imaging, Inc.
- Date Received
- September 18, 1986
- Decision Date
- September 26, 1986
- 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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