FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
TECA PREMIERE
K Number: K953732
·
Decision Oct 19, 1995
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
8
Review Days
80
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Basic Information
- Device Name
- TECA PREMIERE
- K Number
- K953732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medelec , Ltd.
- Date Received
- July 31, 1995
- Decision Date
- October 19, 1995
- 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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Other Clearances by Medelec , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K965065 | TECA. MILLENNIUM | Jun 20, 1997 | Substantially Equivalent |
| K964280 | DG NERVUS | Jan 27, 1997 | Substantially Equivalent |
| K954157 | DG PORTABLE SYSTEM | Jan 17, 1996 | Substantially Equivalent |
| K953799 | DG EXAMINER PLUS | Nov 8, 1995 | Substantially Equivalent |
| K934670 | DG 3P SYSTEM | May 25, 1994 | Substantially Equivalent |
| K934669 | ARC | Apr 26, 1994 | Substantially Equivalent |
| K923303 | SAPPHIRE PREMIERE | Nov 24, 1992 | Substantially Equivalent |