Teca Model B9 Electromyograph
FDA 510(k) K781399 · Teca, Inc.
510(k) numberK781399
Submission
- Device name
- Teca Model B9 Electromyograph
- Applicant
- Teca, Inc.
Mchenry, IL, US - Received
- August 15, 1978
- Decision date
- September 20, 1978
- 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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| K894889 | Teca Neuromapper 386OLT · Traditional | 12/22/1989SE |
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| 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 |
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Questions and answers
When was Teca Model B9 Electromyograph cleared by the FDA?
Teca Model B9 Electromyograph (K781399) received a 510(k) decision of Substantially Equivalent on September 20, 1978, 36 days after the submission was received.
What is the product code of K781399?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.