FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
K Number: K132306
·
Decision Nov 21, 2013
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
4
Review Days
120
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Basic Information
- Device Name
- PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
- K Number
- K132306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Persyst Development Corp.
- Date Received
- July 24, 2013
- Decision Date
- November 21, 2013
- Product Code
- OMB
- 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 |
|---|---|---|---|
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | FDA class 2 | Neurology |
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