FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
K Number: K871964
·
Decision Oct 1, 1987
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
6
Review Days
134
Basic Information
- Device Name
- SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
- K Number
- K871964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- SIEGEN CORP.
- Date Received
- May 20, 1987
- Decision Date
- October 1, 1987
- 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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Other Clearances by SIEGEN CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K861884 | NEUROSCOPE SEEG | Oct 14, 1986 | 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 |