Emg/Ncv & Evoked Response, Design W/
FDA 510(k) K843253 · Neurodiagnostics, Inc.
510(k) numberK843253
Submission
- Device name
- Emg/Ncv & Evoked Response, Design W/
- Applicant
- Neurodiagnostics, Inc.
Santa Ana, CA, US - Received
- August 20, 1984
- Decision date
- November 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
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Questions and answers
When was Emg/Ncv & Evoked Response, Design W/ cleared by the FDA?
Emg/Ncv & Evoked Response, Design W/ (K843253) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 92 days after the submission was received.
What is the product code of K843253?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.