FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K Number: K850108
·
Decision Apr 11, 1985
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
426
Applicant Total
26
Review Days
91
Basic Information
- Device Name
- EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
- K Number
- K850108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- NICOLET BIOMEDICAL INSTRUMENTS
- Date Received
- January 10, 1985
- Decision Date
- April 11, 1985
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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