FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)
K Number: K863136
·
Decision Sep 4, 1987
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
2
Review Days
385
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Basic Information
- Device Name
- HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)
- K Number
- K863136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Neurotechnics, Inc.
- Date Received
- August 15, 1986
- Decision Date
- September 4, 1987
- Product Code
- GXZ
- 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 |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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Other Clearances by Neurotechnics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863135 | LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) | Sep 4, 1987 | Substantially Equivalent |