FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 8 EEG PREAMPLIFIER
K Number: K863124
·
Decision Nov 18, 1986
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
6
Review Days
96
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Basic Information
- Device Name
- MODEL 8 EEG PREAMPLIFIER
- K Number
- K863124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro Tronics Corp.
- Date Received
- August 14, 1986
- Decision Date
- November 18, 1986
- 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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| K862527 | SLEEP ANALYZING COMPUTER | Oct 6, 1986 | Substantially Equivalent |
| K780838 | PERCI | Jul 17, 1978 | Substantially Equivalent |
| K772005 | MYOTONE EMG MONITOR | Nov 23, 1977 | Substantially Equivalent |