FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
K Number: K001705
·
Decision Jun 29, 2000
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
11
Review Days
24
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Basic Information
- Device Name
- STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
- K Number
- K001705
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chester Labs, Inc.
- Date Received
- June 5, 2000
- Decision Date
- June 29, 2000
- 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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