Teca #Te 8
FDA 510(k) K812715 · Teca, Inc.
510(k) numberK812715
Submission
- Device name
- Teca #Te 8
- Applicant
- Teca, Inc.
Mchenry, IL, US - Received
- September 25, 1981
- Decision date
- October 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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More from Spinematrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962283 | EEG ElectrodesGXY · Traditional | 12/16/1996SE |
| K903731 | Sapphire Series 1P, 1L, 2L, and 2MEGWF · Traditional | 02/04/1991SE |
| K903004 | EE1114, 1118, 1121 Electro-EncephalographGWQ · Traditional | 11/15/1990SE |
| K896666 | P460, DG32 ElectroencephalographGWQ · Traditional | 02/16/1990SE |
| K894889 | Teca Neuromapper 386OLT · Traditional | 12/22/1989SE |
| K894088 | Teca Neuromapper 1620, Brain MapperOLT · Traditional | 11/15/1989SE |
| K890881 | Teca 1A96, 1A97 and 1A98 ElectroencephalographsGWQ · Traditional | 03/23/1989SE |
| K884870 | Teca/Medelec 'Concept' P420GWF · Traditional | 02/23/1989SE |
| K880593 | Teca/Medelec MistralGWE · Traditional | 04/06/1988SE |
| K872931 | Teca/Medelec TTT Thermal Threshold TesterLLN · Traditional | 11/16/1987SE |
Questions and answers
When was Teca #Te 8 cleared by the FDA?
Teca #Te 8 (K812715) received a 510(k) decision of Substantially Equivalent on October 13, 1981, 18 days after the submission was received.
What is the product code of K812715?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.