FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG-GEL ELECTRODE GEL
K Number: K833172
·
Decision Nov 21, 1983
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- ECG-GEL ELECTRODE GEL
- K Number
- K833172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Whs Products, Inc.
- Date Received
- September 16, 1983
- Decision Date
- November 21, 1983
- 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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