FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECA NEUROMAPPER 1620, BRAIN MAPPER
K Number: K894088
·
Decision Nov 15, 1989
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
53
Applicant Total
29
Review Days
160
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Basic Information
- Device Name
- TECA NEUROMAPPER 1620, BRAIN MAPPER
- K Number
- K894088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Teca, Inc.
- Date Received
- June 8, 1989
- Decision Date
- November 15, 1989
- Product Code
- OLT
- 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 |
|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | FDA class 2 | Neurology |
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Other Clearances by Teca, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962283 | EEG ELECTRODES | Dec 16, 1996 | Substantially Equivalent |
| 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 |
| 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 |