FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERSYST PRISM
K Number: K974718
·
Decision Mar 9, 1998
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- PERSYST PRISM
- K Number
- K974718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1420
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Persyst Development Corp.
- Date Received
- December 17, 1997
- Decision Date
- March 9, 1998
- Product Code
- GWS
- 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 |
|---|---|---|---|
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | FDA class 1 | Neurology |
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