Teca MS-20 Mystro Electrophysiological
FDA 510(k) K842886 · Teca, Inc.
510(k) numberK842886
Submission
- Device name
- Teca MS-20 Mystro Electrophysiological
- Applicant
- Teca, Inc.
Pleasantiville, NY, US - Received
- July 23, 1984
- Decision date
- December 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K890881 | Teca 1A96, 1A97 and 1A98 ElectroencephalographsGWQ · Traditional | 03/23/1989SE |
| K884870 | Teca/Medelec 'Concept' P420GWF · Traditional | 02/23/1989SE |
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Questions and answers
When was Teca MS-20 Mystro Electrophysiological cleared by the FDA?
Teca MS-20 Mystro Electrophysiological (K842886) received a 510(k) decision of Substantially Equivalent on December 12, 1984, 142 days after the submission was received.
What is the product code of K842886?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.