FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROSCOPE SEEG
K Number: K861884
·
Decision Oct 14, 1986
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
6
Review Days
152
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Basic Information
- Device Name
- NEUROSCOPE SEEG
- K Number
- K861884
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Siegen Corp.
- Date Received
- May 15, 1986
- Decision Date
- October 14, 1986
- Product Code
- GWO
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
Similar 510(k) Clearances
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Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
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Other Clearances by Siegen Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871964 | SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU. | Oct 1, 1987 | Substantially Equivalent |
| K862430 | SIEGEN HEADPHONES | Sep 26, 1986 | Substantially Equivalent |
| K844616 | SIEGEN VISUAL STIMULATOR | Feb 14, 1985 | Substantially Equivalent |
| K844646 | SIEGEN SURFACE ELECTRODES | Dec 11, 1984 | Substantially Equivalent |
| K843464 | SIEGEN NEUROSCOPE | Nov 20, 1984 | Substantially Equivalent |