FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO-GEL
K Number: K111717
·
Decision Jan 5, 2012
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
3
Review Days
199
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Basic Information
- Device Name
- ELECTRO-GEL
- K Number
- K111717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro-Cap Intl., Inc.
- Date Received
- June 20, 2011
- Decision Date
- January 5, 2012
- Product Code
- GYB
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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