FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
K Number: K001324
·
Decision Jul 11, 2000
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
53
Applicant Total
3
Review Days
76
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Basic Information
- Device Name
- SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
- K Number
- K001324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuro Scan Labs
- Date Received
- April 26, 2000
- Decision Date
- July 11, 2000
- 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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