FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K Number: K813009
·
Decision Dec 14, 1981
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
29
Review Days
48
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Basic Information
- Device Name
- TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
- K Number
- K813009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Teca, Inc.
- Date Received
- October 27, 1981
- Decision Date
- December 14, 1981
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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|---|---|---|---|
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| K884870 | TECA/MEDELEC 'CONCEPT' P420 | Feb 23, 1989 | Substantially Equivalent |
| K880593 | TECA/MEDELEC MISTRAL | Apr 6, 1988 | Substantially Equivalent |
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