FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
QSI 9500
K Number: K904294
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
11
Applicant Total
3
Review Days
314
Basic Information
- Device Name
- QSI 9500
- K Number
- K904294
- 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 19, 1990
- Decision Date
- July 30, 1991
- Product Code
- OLU
- 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 |
|---|---|---|---|
| OLU | Normalizing Quantitative Electroencephalograph Software | FDA class 2 | Neurology |
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