FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K Number: K963208
·
Decision Jul 14, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
2
Review Days
332
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Basic Information
- Device Name
- NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
- K Number
- K963208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neurotron Medical
- Date Received
- August 16, 1996
- Decision Date
- July 14, 1997
- Product Code
- JXE
- 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 |
|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | FDA class 2 | Neurology |
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Other Clearances by Neurotron Medical
| K Number | Device Name | ||
|---|---|---|---|
| K053214 | THERAKNIT GARMENT ELECTRODE | Dec 20, 2005 | Substantially Equivalent |