FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECA MODEL B9 ELECTROMYOGRAPH
K Number: K781399
·
Decision Sep 20, 1978
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
74
Applicant Total
29
Review Days
36
Basic Information
- Device Name
- TECA MODEL B9 ELECTROMYOGRAPH
- K Number
- K781399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- TECA, INC.
- Date Received
- August 15, 1978
- Decision Date
- September 20, 1978
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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Other Clearances by TECA, INC.
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|---|---|---|---|
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| 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 |