FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EEG 130
K Number: K842288
·
Decision Jul 17, 1984
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
6
Review Days
71
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Basic Information
- Device Name
- EEG 130
- K Number
- K842288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Calnor of EL Paseo, Inc.
- Date Received
- May 7, 1984
- Decision Date
- July 17, 1984
- Product Code
- HCC
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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Other Clearances by Calnor of EL Paseo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841895 | GSR, 126, EEG 130-TEMP. 132, EMG 133 | Jul 17, 1984 | Substantially Equivalent |
| K842353 | TEMPERATURE 132 | Jul 17, 1984 | Substantially Equivalent |
| K842354 | EMG MODEL 133 | Jul 17, 1984 | Substantially Equivalent |
| K834152 | ETHYLENE OXIDE DETECTOR GLD-1-07 | Mar 19, 1984 | Substantially Equivalent |
| K771577 | CLINICAL EMG MODEL 133 | Aug 26, 1977 | Substantially Equivalent |