FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K Number: K903731
·
Decision Feb 4, 1991
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
29
Review Days
172
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Basic Information
- Device Name
- SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
- K Number
- K903731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Teca, Inc.
- Date Received
- August 16, 1990
- Decision Date
- February 4, 1991
- Product Code
- GWF
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 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 |
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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 |
| K862906 | TECA/MEDELEC AS-10 SENSOR | Feb 4, 1987 | Substantially Equivalent |