FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
K Number: K855232
·
Decision Jul 3, 1986
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
4
Review Days
185
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Basic Information
- Device Name
- SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
- K Number
- K855232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Neuroscience, Inc.
- Date Received
- December 30, 1985
- Decision Date
- July 3, 1986
- Product Code
- GWF
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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