FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K Number: K002969
·
Decision Dec 8, 2000
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
3
Review Days
77
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Basic Information
- Device Name
- XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
- K Number
- K002969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xltek
- Date Received
- September 22, 2000
- Decision Date
- December 8, 2000
- 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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