FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROENCEPHALOGRAPH EEG
K Number: K850259
·
Decision Apr 11, 1985
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
26
Review Days
79
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Basic Information
- Device Name
- ELECTROENCEPHALOGRAPH EEG
- K Number
- K850259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Nicolet Biomedical Instruments
- Date Received
- January 22, 1985
- Decision Date
- April 11, 1985
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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|---|---|---|---|
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| K873964 | NICOLET DISPOSABLE PRASS PROBE | Nov 20, 1987 | Substantially Equivalent |
| K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM | Oct 26, 1987 | Substantially Equivalent |
| K871678 | NICOLET AMP 6R11 SYSTEM | Jul 16, 1987 | Substantially Equivalent |
| K862592 | PHOENIX SYSTEM SEVEN. | Sep 16, 1986 | Substantially Equivalent |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | Nov 27, 1985 | Substantially Equivalent |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | Apr 11, 1985 | Substantially Equivalent |
| K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | Apr 11, 1985 | Substantially Equivalent |
| K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF | Apr 11, 1985 | Substantially Equivalent |