FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EEG ELECTRODES
K Number: K962283
·
Decision Dec 16, 1996
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
29
Review Days
186
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EEG ELECTRODES
- K Number
- K962283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teca, Inc.
- Date Received
- June 13, 1996
- Decision Date
- December 16, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
FDA 510(k)
FDA Class 2
·Neurology
MR Conditional Cup Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Tutamen Self Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
FDA 510(k)
FDA Class 2
·Neurology
Ceribell Brain Monitor Headband
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Teca, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903731 | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME | Feb 4, 1991 | Substantially Equivalent |
| K903004 | EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH | Nov 15, 1990 | Substantially Equivalent |
| K896666 | P460, DG32 ELECTROENCEPHALOGRAPH | Feb 16, 1990 | Substantially Equivalent |
| K894889 | TECA NEUROMAPPER 386 | Dec 22, 1989 | Substantially Equivalent |
| K894088 | TECA NEUROMAPPER 1620, BRAIN MAPPER | Nov 15, 1989 | Substantially Equivalent |
| K890881 | TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS | Mar 23, 1989 | Substantially Equivalent |
| K884870 | TECA/MEDELEC 'CONCEPT' P420 | Feb 23, 1989 | Substantially Equivalent |
| K880593 | TECA/MEDELEC MISTRAL | Apr 6, 1988 | Substantially Equivalent |
| K872931 | TECA/MEDELEC TTT THERMAL THRESHOLD TESTER | Nov 16, 1987 | Substantially Equivalent |
| K862906 | TECA/MEDELEC AS-10 SENSOR | Feb 4, 1987 | Substantially Equivalent |