FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
EAV COMBI-2
K Number: K020565
·
Decision Apr 30, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
25
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- EAV COMBI-2
- K Number
- K020565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vibrant Health
- Date Received
- February 20, 2002
- Decision Date
- April 30, 2002
- Product Code
- GZO
- 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 |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | FDA class 2 | Neurology |
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